| Primary | Proportion of Patients Without Any Need for INV Until EoS | Number of Participants Stratified as those With and Without the Need for INV Until End-of-study (EoS). For this outcome a worst case approach was used in which patients who were lost to follow-up or who discontinued the trial on or before Day 13 due to any other reason than death and discontinued with a last observed WHO clinical status no lower than that at Screening, and patients who died were considered as patients requiring INV. | | Posted | | Count of Participants | | Participants | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| No INV needed | | | INV needed | |
|
| |
| Secondary | Days in ICU Department | Duration of ICU Treatment Until EoS for Only Patients Who Were Admitted to the ICU During the Trial. | | Posted | | Mean | Standard Deviation | days | | Throughout the Study (Day 0 to Day 28 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | All Cause Mortality (ITT Approach) | 28-day All-cause Mortality (including lost to follow-up): 'all-cause-mortality' includes all confirmed deaths and patients who discontinued the trial before Day 28 and for whom no outcome (alive or dead) could be determined at EoS; 'actual death' includes only those patients for which a fatal outcome was confirmed by Day 28. | | Posted | | Count of Participants | | Participants | | Throughout the Study (Day 0 to Day 28 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Time to Clinical Improvement | Defined as the time from first dose of investigational medicinal product (IMP) to an improvement of at least 2 points on the Modified WHO Ordinal Scale for Clinical Status (Modified WHO Ordinal Scale for Clinical Status), or live discharge from hospital without oxygen supplementation, whichever comes first. The 50% Kaplan-Meier quartile (median) of actual values per treatment arm is provided as outcome of this variable below. | | Posted | | Median | 90% Confidence Interval | days | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Days of Hospitalization | Duration of hospitalization (for US sites only: or treatment in special outpatient setting in lieu of hospitalization due to resource restraints)cacy: | Patients from Bulgaria were excluded because they had to stay in hospital for the entire treatment period as per protocol. | Posted | | Mean | Standard Deviation | days | | Throughout the Study (Day 0 to Day 28 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Patients Free of Renal-replacement Therapy (RRT)* Until EoS | Number of Patients Both for All Patients and Surviving Patients Free of Renal-replacement Therapy (RRT)* Until EoS | | Posted | | Count of Participants | | Participants | | Throughout the Study (Day 0 to Day 28 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Patients Required ECMO Until EoS | Number and Percentage of patients both for all patients and surviving patients free from extracorporeal membrane oxygenation (ECMO)* until EoS. | If ECMO was prescribed but was not started, the patient is considered as being not free of ECMO. Patients with ECMO documented are included with 'no' in analysis of all following visits (irrespective of whether visit was done). Patients without ECMO documented are excluded from analysis of visits after their last performed visit. | Posted | | Count of Participants | | Participants | | Throughout the Study (Day 0 to Day 28 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Patients Free of INV Until Day 14* | Number and persentage of patients free of INV until Day 14* | Patients without INV documented in group IMU-838 and Placebo group ( 7 and 10 accordingly) were excluded from analysis of visits after their last performed visit | Posted | | Count of Participants | | Participants | | Throughout the Study (Day 0 to Day 14 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Patients Free of RRT | Percentage of patients free of RRT until Day 14* | Patients without RRT documented are excluded from analysis of visits after their last performed visit. | Posted | | Count of Participants | | Participants | | Day 0 to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Number of Patients Free of ECMO | Number of patients free of ECMO until Day 14. | If ECMO was prescribed but was not started, the patient is considered as being not free of ECMO. Patients with ECMO documented are included with 'no' in analysis of all following visits (irrespective of whether visit was done). Patients without ECMO documented are excluded from analysis of visits after their last performed visit. | Posted | | Count of Participants | | Participants | | Day 0 to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Patients With Improvement of at Least 2 Points (From Randomization) on the 9-category WHO Ordinal scale1 | Numbers of patients with improvement of at least 2 points (from randomization) on the 9-category WHO ordinal scale1( Modified WHO Ordinal Scale for Clinical Status)on Days 6, 14, and 28, where score 0 means no clinical or virological evidence of infection and score 8 is the worth outcome ( mens death). | | Posted | | Number | | participants | | on Days 6, 14, and 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Patients With Auxiliary Oxygen Therapy (Including All Types of Oxygen Therapy) | Percentage of Patients with auxiliary oxygen therapy (including all types of oxygen therapy) on Days 6, 14, and 28. | Patients without axillary oxygen therapy documented were excluded from analysis of visits after their last performed visit. Numbers of participants analyzed changed across time points. | Posted | | Number | | percentage of participants | | on Days 6, 14, and 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Patients With Clinical Recovery | Percentage of Patients With Clinical Recovery: Axillary Temp <= 36.6 °C, or Oral Temp <= 37.2 °C, or Rectal or Tympanic Temp <= 37.8 °C and Respiratory Frequency <= 24 Times/Min Without O2 Inhalation and O2 Saturation >= 98% Without O2 Inhalation | Clinical recovery was only assumed if it was confirmed in the evening and at the next visit. | Posted | | Number | | percent of patients | | Throughout the Study (Day 0 to Day 28 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Patients With Clinical Recovery | Percentage of Patients With Clinical Recovery Oxygen Saturation ≥98% Without Oxygen Inhalation | | Posted | | Number | | percent of patients | | Throughout the Study (Day 0 to Day 28 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Patients With Clinical Improvement or Live Discharge From Hospital Without Oxygen Supplementation | Percentage of patients with clinical improvement, defined as the time from first dose of IMP to an improvement of at least 2 points on the WHO 9 category ordinal scale, or live discharge from hospital without oxygen supplementation, whichever comes first (Modified WHO Ordinal Scale for Clinical Status, where score 0 - for patient with no clinical or virological evidence of infections, score 9 - the worth scenario- death) | One patient from group IMU-838 was excluded from this analysis due to hospital discharge before start of treatment. | Posted | | Number | | percent of patients | | Throughout the Study (Day 0 to Day 28 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
|
| Secondary | Percentage of Participants With WHO Status<=2 | Clinical patient status on the 9-category WHO ordinal scale1 on Days 6, 14, and 28 | | Posted | | Number | | percentage of patients, WHO status <=2 | | on Days 6, 14, and 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Duration of INV | Duration of INV throughout the study. If no entry on the respective CRF page exists, the duration is set to 0 days for patients who performed Day 28 visit. Patients without Day 28 visit and without any entry on the respective CRF page are excluded from analysis. | Patients who are lost to follow-up or discontinued the trial on or before Day 13 (last treatment day) due to any other reason than death and discontinue with a last observed WHO clinical status, and patients who die before Day 28 will be considered treatment failures (i.e. having a need for INV) for the primary endpoint. | Posted | | Mean | Inter-Quartile Range | days | | Throughout the Study (Day 0 to Day 28 ) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
|
| Secondary | Days on ECMO | Duration of ECMO in days (duration set to 0 for those who did not require ECMO). No participants required ECMO. | patients, who require ECMO throughout the study | Posted | | Number | | days | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Days on RRT | Duration of RRT in days (duration set to 0 for those who did not require RRT).No participants required RRT. | patients , who require RRT throughout the study | Posted | | Number | | days | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Days of Auxiliary Oxygen Therapy | Duration of auxiliary oxygen therapy (including all types of oxygen therapy) | 106 and 107 participants respectively were studied. Only participants who required auxiliary oxygen therapy were selected. If auxiliary oxygen therapy started before randomization, time of randomization is used as start time.Patients who are lost to follow-up or discontinue prematurely without Day 28 and without any auxiliary oxygen therapy documented are excluded from analysis. | Posted | | Mean | Standard Deviation | days | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Days of Hospitalization | Duration of hospitalization for survivors | Patients enrolled in centers in Bulgaria (N = 37 in the 45 mg IMU-838 group and N = 33 in the placebo group) were excluded from the analysis as, per protocol, they were required to remain hospitalized for the entire treatment period | Posted | | Mean | Inter-Quartile Range | days | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Participants With ICU Admission | Percentage of Participants with ICU Admission at different time point | Patients without ICU documented were excluded from analysis of visits after their last performed visit. | Posted | | Number | | percent of patients | | on Days 6, 14, and 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Probability of Death | Probability of death derived from Kaplan Meier analyses | | Posted | | Number | | Probability | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Days to INV | Time to first prescription of invasive ventilation (INV). The time to first prescription of INV, only patients with actual INV or prescription for INV are considered. | Only 2 patients had confirmed use of INV throughout the study and were included in the analysis. | Posted | | Median | Full Range | days | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Days to RRT | Time to first prescription of RRT | No patients required RRT during the trial | Posted | | | | | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Days to ECMO | Time to first prescription of ECMO | No patients required ECMO during the trial | Posted | | | | | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Days to INV, RRT and ECMO | Time to first prescription of INV, RRT, and ECMO. The time to first prescription of INV, only patients with actual INV or prescription for INV are considered. | Only 2 patients had confirmed use of INV throughout the study and were included in the analysis. No patients required RRT or ECMO during the trial. | Posted | | Median | Full Range | days | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Probability of ICU Admission | Overall probability of ICU admission derived from Kaplan Meier analyses. | | Posted | | Number | | Probability | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Cumulative Dose | Cumulative Dose of Vasoactive Therapies and Days With Vasoactive Therapies (Daily Until Day 14) | Vasoactive therapy was prescribed for only 1 patient in the IMU-838 group for a single day . If no vasoactive therapy was given, cumulative dose is set to 0. | Posted | | Mean | Standard Deviation | mg | | Day 0 to day 14 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. |
| |
| Secondary | Time to Clinical Recovery | Time of first assessments of parameters contributing to clinical recovery | The first clinical recovery is counted when later relapses are absent. Except for Day 28/early termination/last day with non-missing assessment, only events where clinical recovery is confirmed on the next visit with non-missing assessment(s) are counted. For Day 28/early termination/last day with non-missing assessment this confirmation is not needed. EoS can be > 28 days as due to COVID-19 restrictions some patients came late (up to Day 42), which was considered a minor protocol deviation. | Posted | | Median | 90% Confidence Interval | days | | Throughout the Study (Day 0 to EoS [Day 27 up to Day 42]) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
|
| Secondary | Plasma Levels of IMU-838 | Morning trough plasma levels of IMU-838 on Days 0, 1, 2, 3, 6, 14, and 28 | Placebo group not available | Posted | | Mean | Standard Deviation | ug/mL | | on Days 0, 1, 2, 3, 6, 14, and 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. |
| |
| Secondary | Correlation of Trough Levels (Quartiles) to Selected Clinical Outcomes | Kaplan-Meier analyses were used to investigate a potential relationship between trough plasma levels of IMU-838 and time to clinical improvement and time to clinical recovery. Estimates of the clinical outcomes were evaluated separately for patients within each of the four quartiles of IMU-838 trough levels at Day 14. | The safety analysis set consisting of all randomized patients who received at least one dose of IMU-838. | Posted | | Median | 90% Confidence Interval | days | | Trough levels at Day 14; Clinical outcome: Day 0 to EoS (EoS = Day 27 up to Day 42) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | 110 participants analyzed, who received twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. |
| |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious AEs | Adverse events (AEs) and serious AEs. AEs-Hypertriglyceridemia,Increased glycosylated hemoglobin, Headache, Thrombocytosis, Hyperglycemia, AEs reported in ≥ 2.0% of patients in any treatment group included anemia, bradycardia, sinus bradycardia, tachycardia, pyrexia, hepatocellular injury, hematuria, hypertension and hypertensive crisis. SAEs- deep vein thrombosis,COVID-19 pneumonia, patient death. | | Posted | | Count of Participants | | Participants | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Vital Signs: Height | Safety Height in centimeters will be recorded without shoes. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE. | For 55 female and 55 male in group IMU-838 and 46 female and 64 male in Placebo group | Posted | | Mean | Standard Deviation | centimeters | | at Baseline | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | For 55 female and 55 male in this group: twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | For 46 female and 64 male in this group: twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Vital Signs: Weight | Safety Weight in kilograms will be recorded without shoes. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE. | For 55 female and 55 male in group IMU-838 and 46 female and 64 male in Placebo group. | Posted | | Mean | Standard Deviation | kilograms | | at Baseline | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | For 55 female and 55 male in this group: twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | For 46 female and 64 male in this group: twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Vital Signs: Body Temperature (ºC) | Safety Body temperature can be measured axillary, oral, rectal or tympanic, but should be always measured by the same method for a patient. Changes in vital signs judged by the investigator as clinically significant will be reported as an AE. | | Posted | | Mean | Standard Deviation | degrees Celsius | | at Baseline | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Albumin Concentration at Various Time Points | Clinical laboratory parameters: blood chemistry (Albumin concentration at various time points) | | Posted | | Mean | Standard Deviation | g/L | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Hematocrit Ratio at Various Time Points | Clinical laboratory parameters: hematology- Hematocrit ratio at various time points | | Posted | | Mean | Standard Deviation | ratio | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Urine Creatinine at Various Time Points | Clinical laboratory parameters: urinalysis- Urine creatinine at various time points | | Posted | | Mean | Standard Deviation | umol/L | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Temperature | Temperature data at different time point. | | Posted | | Mean | Standard Deviation | degrees Celsius | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | D-dimer | | | Posted | | Median | Full Range | ng/mL | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Lactate Dehydrogenase (LDH) | Blood levels of disease markers | | Posted | | Median | Full Range | nkat/L | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | C-reactive Protein | Blood levels of disease markers | | Posted | | Median | Full Range | nmol/L | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Troponin I | Bood levels of disease markers | | Posted | | Median | Full Range | ug/L | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Procalcitonin | Blood levels of disease markers | | Posted | | Median | Full Range | ng/mL | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Correlation of Time to Clinical Improvement With Quartiles of D-Dimer Blood Levels at Day 6 | Kaplan-Meier analyses were used to investigate a potential relationship between blood levels of D-Dimer and time to clinical improvement. Estimates of the clinical outcome were evaluated separately for patients within each of the four quartiles of D-Dimer levels at Day 6. | Safety analysis set consisting of all randomized patients who received at least one dose of IMP. | Posted | | Median | 90% Confidence Interval | days | | D-Dimer levels at Day 6; Clinical outcome: Day 0 to EoS (EoS = Day 27 up to Day 42) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Changing in Log 10 Copies in Spontaneous Sputum and Nasopharyngeal Swab Samples at Various Time Points | Virologic markers: Severe Acute Respiratory Syndrome Coronavirus Virus (SARS-CoV-2) Mean Viral Load - log10 Copies in Spontaneous Sputum and Nasopharyngeal Swab Samples: changing of SARS-CoV-2 Viral Load in patients on Days 6,14,28 | | Posted | | Mean | Standard Deviation | Change in log10 copies | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Mean Viral Load - log10 Copies in Spontaneous Sputum and Nasopharyngeal Swab Samples | Virologic markers :Severe Acute Respiratory Syndrome Coronavirus Virus (SARS-CoV-2) mean viral load - log10 copies in spontaneous sputum and nasopharyngeal swab samples: Time course of SARS-CoV-2 viral load | | Posted | | Mean | Standard Deviation | log10 Copies | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Number of Participants With 2 Consecutive Negative SARS-CoV-2 Reverse Transcriptase Polymerase Chain Reaction Tests at Least 24 Hours Apart | Virologic markers: Qualitative Virologic Clearance in Spontaneous Sputum and Nasopharyngeal Swab Samples (= 2 Consecutive Negative SARS-CoV-2 Reverse Transcriptase Polymerase Chain Reaction Tests at Least 24 Hours Apart) | | Posted | | Count of Participants | | Participants | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Rate of Conversion to a Negative SARS-CoV-2 (Qualitative) Test | Virologic markers: conversion to a negative SARS-CoV-2 (qualitative) test on Day 28. | | Posted | | Count of Participants | | Participants | | on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Time to Conversion to a Negative SARS-CoV-2 (Qualitative) Test | Virologic markers : Time to Conversion to a Negative SARS-CoV-2 (Qualitative) Test Throughout the study. Only patients with viral load measured from nasopharyngeal swab and results provided by the central laboratory (Covance) were included.Conversion to a negative SARS-CoV-2 status is only assumed if a negative test is confirmed by all available subsequent assessments. This means for Day 28/early termination visit no confirmation is needed. If no conversion to a negative status is documented, patients will be censored for survival analysis at the time of the last documented positive test result. | | Posted | | Mean | 90% Confidence Interval | days | | Throughout the Study (Day 0 to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
|
| Secondary | Interleukin (IL)-17 | The profiles of immune system biomarkers | | Posted | | Mean | Standard Deviation | pg/mL | | Day 0, 6, 14 and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Interleukin (IL)-1ß | The profiles of immune system biomarkers | | Posted | | Mean | Standard Deviation | ng/L | | Day 0, 6, 14 and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Interleukin (IL)-6 | The profiles of immune system biomarkers | | Posted | | Mean | Standard Deviation | ng/L | | Day 0, 6, 14 and 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Interferon Gamma (IFNγ) | The profiles of immune system biomarkers | | Posted | | Mean | Standard Deviation | pg/mL | | Day 0, 6, 14 and 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
| |
| Secondary | Tumor Necrosis Factor Alpha | The profiles of immune system biomarkers | | Posted | | Mean | Standard Deviation | ng/L | | Day 0, 6, 14 and 28 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
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| Secondary | Immunoglobulin (Ig)A and/or IgG Antibodies Against SARS-CoV-2 | Proportion of patients with IgA and/or IgG antibodies against SARS-CoV-2on at different time point | Not all 220 patients were negative for SARS-CoV-2 in nasopharyngeal samples analyzed by the central laboratory throughout the study. Patients, where the reported result for IgA and IgG antibodies is "limit", are considered as "negative" for analysis. | Posted | | Number | | percent of patients | | Day 6, 14 and 28 | | | | ID | Title | Description |
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| OG000 | IMU-838 | twice-daily (BID) oral 22.5 mg IMU-838 (45 mg/day + SoC) IMU-838: Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable). If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube. | | OG001 | Placebo | twice-daily (BID) oral placebo (+ SoC) Placebo: Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838 |
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