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Multicenter double-blind placebo-controlled parallel-group randomized clinical trial of efficacy and safety of Raphamin in the treatment of coronavirus disease 2019 in outpatients.
Design: multicenter, double blind, placebo-controlled, parallel group randomized clinical trial.
The study enrolls outpatients of either gender aged 18-75 years with increased body temperature > 37.5°C and other upper respiratory infection symptoms (cough, chest congestion, sore throat, nasal congestion/moderate rhinorrhea). The investigator should specify the patient's status of vaccination for COVID-19, influenza and other infections. Patients within the first four weeks after any vaccination/booster vaccination are not considered as candidates to participate in the study.
Nasopharyngeal swabs and rapid COVID-19 test are made after signing informed consent (two versions are used: 1) for patients consented for laboratory tests; 2) for patients without the consent).
Patients with a positive rapid test and presence of mild COVID-19 (upper respiratory infection symptoms, no symptoms of moderate or severe forms) within 24 hours after manifestation of the first disease symptoms are considered as candidates for the study. Oxygen saturation (SpO2) is measured by pulse oximetry in all patients (pulse oximeters are provided by the study sponsor). If SpO2 is ≥95%, a patient may be selected for the study. Baseline severity for COVID-19 symptoms is evaluated using the scoring system "Assessment of 14 Common COVID-19-Related Symptoms" (FDA, 2020). This scoring system assesses the follows symptoms:
Each symptom is scored individually using the following scoring values:
The minimal baseline score for COVID-19-related symptoms is defined as follows: at least two symptoms with a score of 2 or higher, with the exception of taste and smell where subjects may have a score of 1 or higher, and the absence of shortness of breath (difficulty breathing).
If more severe symptoms are presented, the patient is not included in the study. The therapeutic approach is determined by the current edition of the clinical recommendations of the Ministry of Health of the Russian Federation "Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19)".
At visit 1 (Day 1), in addition to rapid COVID-19 test and SpO2 measurement, the investigator will collect complaints and medical history of the patient, perform objective examination including vital signs (blood pressure, heart rate and respiration rate), record concomitant diseases and concomitant therapy, perform nasopharyngeal smearing for further PCR for SARS-CoV-2, laboratory tests will be made (if the patient gave his/her consent for blood and urine sampling).
Patients who meet all the inclusion criteria and do not have exclusion criteria at Visit 1 (Day 1) are randomized into one of two groups: patients in group 1 receive Raphamin for 5 days; patients in group 2 receive placebo according to the Raphamin regimen.
If positive PCR test is received (confirmation of new coronavirus disease COVID-19), the patient continues to participate in the study. If PCR result is negative, the patient completes participation in the study ahead of schedule, and his further therapy is determined by the investigator in accordance with the standard of care.
Electronic patient diary (EPD) is utilized in the study where morning and evening axillary temperature records are made with the time of measurement. The sponsor provides a classical mercury-free thermometer to each patient. In addition, presence and severity of the disease symptoms according to the scoring system "Assessment of 14 Common COVID-19-Related Symptoms", antipyretics administration and probable worsening of disease duration should also be recorded in EPD. All patients are provided with paracetamol. The physician instructs the patient how to fill in the diary. The EPD is available for filling in within 28 days of participation in the study.
Overall, patients are observed for 28 days (screening and randomization up to 1 day, treatment for 5 days, follow-up till 28th day).
During the study, six visits are planned: on days 1, 3, 6, 10, 21, and 28 (visits 1, 2, 3, 4, 5, and 6). Visits 1, 3, and 4 are in person (visits to the patient or visits to the medical center) when the physician examines the patient and monitors EPD records. At visit 3, the patient's adherence to treatment is assessed and laboratory tests are performed. Visits 2, 5 and 6 are phone surveys to determine the patient's condition, presence/absence of complaints. In case of worsening of disease duration, the physician makes an extra visit. Patients with COVID-19 progression to more severe form as well as hospitalized patients are considered as reaching the study endpoints and terminate participation in the study ahead of schedule. The therapeutic approach is determined by the current edition of the clinical recommendations of the Ministry of Health of the Russian Federation "Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19)".
During the study, the use of paracetamol and medicines for the treatment of concomitant diseases is allowed, with the exception of the drugs specified in the section "Prohibited concomitant treatment".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raphamin | Experimental | Tablet for oral use. |
|
| Placebo | Placebo Comparator | Tablet for oral use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raphamin | Drug | Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. On the first day, 8 tablets should be administered using the following regimen: 1 tablet every 30 minutes in the first 2 hours (5 tablets in total within 2 hours), then additionally one tablet 3 times with regular time intervals. From day 2 onwards, 1 tablet taken 3 times daily. The treatment period is 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With COVID-19 Progression to a More Severe Form | Severity of COVID-19 is assessed in accordance with criteria presented in the current edition of the clinical recommendations of the Ministry of Health of the Russian Federation "Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19)". | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Sustained Clinical Recovery After New Coronavirus Disease COVID-19. | Sustained clinical recovery is a sustained improvement of clinical symptoms for at least 4 consecutive days. The day of improvement is considered the first of these 4 days. Criteria for improvement of clinical symptoms (according to the scoring system "Assessment of 14 Common COVID-19-Related Symptoms") are defined as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to COVID-19 Progression to a More Severe Form | Severity of COVID-19 will be assessed in accordance with the criteria presented in the current edition of the clinical recommendations of the Ministry of Health of the Russian Federation "Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19)". | 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belgorod State National Research University, Department of Hospital Therapy | Belgorod | 308000 | Russia | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Raphamin | Tablet for oral use. Raphamin: Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. On the first day, 8 tablets should be administered using the following regimen: 1 tablet every 30 minutes in the first 2 hours (5 tablets in total within 2 hours), then additionally one tablet 3 times with regular time intervals. From day 2 onwards, 1 tablet taken 3 times daily. The treatment period is 5 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2022 |
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|
|
| Placebo | Drug | Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. Placebo is administered according to the Raphamin regimen. |
|
| 28 days |
| Percentage of Hospitalized Patients | Based on the medical records. | 28 days |
| Percentage of Patients With Negative PCR Test for SARS-CoV-2 |
Number of patients with a negative PCR test result for SARS-CoV-2 on days 6 and 10 of observation. Based on the medical records. |
| On days 6 and 10 |
| Number of Participants With Adverse Events (AEs) | The presence of adverse events. Based on medical records. | From day 1 to day 6 |
| Severity of AEs | The intensity (severity) of adverse events. Based on medical records. | From day 1 to day 6 |
| Causal Relationship of AEs to the Sudy Drug | The causal relationship to the study drug of adverse events. Based on medical records. | From day 1 to day 6 |
| Outcome of AEs | The outcome of adverse events. Based on medical records. | From day 1 to day 6 |
| Changes in Vital Signs: Pulse Rate/Heart Rate in Beats Per Minute (Bpm) | The outcome measure is based on the medical records. The patient's heart rate (heart rate) is measured by the physician in visits 1, 3 and 4 (on days 1 and 6). | On Visit 1 (day 1), Visit 3 (day 6), Visit 4 (day10) |
| Changes in Vital Signs: Respiration Rate/Breathing Rate in Breaths Per Minute | Outcome Measure is based on the medical records. The patient's respiration rate (breathing rate) is measured by physician in visits 1, 3 and 4 (on days 1 and 6). | On Visit 1 (day 1), Visit 3 (day 6), Visit 4 (day10) |
| Changes in Vital Signs: Capillary Blood Oxygen Saturation (SpO2) | Outcome Measure is based on the medical records. The patient's capillary blood oxygen saturation (SpO2) is measured by physician in visits 1, 3 and 4 (on days 1 and 6). | On Visit 1 (day 1), Visit 3 (day 6), Visit 4 (day10) |
| Changes in Vital Signs: Blood Pressure in Units of Millimeters of Mercury (mmHg) | Outcome Measure is based on the medical records. The patient's blood pressure is measured by the physician in visits 1, 3 and 4 (on days 1 and 6). | On Visit 1 (day 1), Visit 3 (day 6), Visit 4 (day10) |
| Percentage of Patients With Clinically Significant Abnormal Laboratory Tests | Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which are beyond the reference values at the end of treatment. | On Visit 1 (day 1) and Visit 3 (day 6) |
| Ivanovo clinical hospital named after Kuvaevs/Polyclinic #10 |
| Ivanovo |
| 153025 |
| Russia |
| Kazan State Medical University, Department of Propedeutics of Internal Diseases named after prof. S.S. Zimnitsky | Kazan' | 420012 | Russia |
| Kazan State Medical University/Department of Infectious Diseases | Kazan' | 420012 | Russia |
| Kirov State Medical University, Hospital Therapy Department | Kirov | 610027 | Russia |
| Kuban State Medical University, Infectious Diseases and Phthisiopulmonology | Krasnodar | 350063 | Russia |
| Clinical hospital "RZD-Medicine" of the city of Nizhny Novgorod | Nizhny Novgorod | 603140 | Russia |
| City Clinical Hospital # 2 | Novosibirsk | 630051 | Russia |
| Clinical Hospital # 4 | Penza | 440067 | Russia |
| LLC "Professor's Clinic" | Perm | 614070 | Russia |
| LLC "Ultrasound Clinic 4D" | Pyatigorsk | 357502 | Russia |
| Ryazan State Medical University named after Academician I.P. Pavlova | Ryazan | 390039 | Russia |
| LLC "BioTechService" | Saint Petersburg | 190121 | Russia |
| City clinic # 44 | Saint Petersburg | 192071 | Russia |
| City Polyclinic # 25 of the Nevsky District | Saint Petersburg | 193312 | Russia |
| LLC "Energy of Health" | Saint Petersburg | 194156 | Russia |
| LLC "Strategic medical systems" | Saint Petersburg | 194291 | Russia |
| Llc "Medical Clinic" | Saint Petersburg | 194356 | Russia |
| LLC "Research Center Eco-safety" | Saint Petersburg | 196143 | Russia |
| JSC "North-West Center for Evidence-Based Medicine" | Saint Petersburg | 196158 | Russia |
| LLC "Clinic Zvezdnaya" | Saint Petersburg | 196158 | Russia |
| City Polyclinic # 43 | Saint Petersburg | 198207 | Russia |
| Lomonosov Interdistrict Hospital named after I.N. Yudchenko | Saint Petersburg | 198412 | Russia |
| City Intercession Hospital | Saint Petersburg | 199106 | Russia |
| LLC "Meili" | Saint Petersburg | 199406 | Russia |
| City polyclinic # 74 | Saint Petersburg | 97762 | Russia |
| Samara City Hospital # 4 | Samara | 443056 | Russia |
| LLC "Center for DNA Research" | Saratov | 410005 | Russia |
| Saratov State Medical University named after V. I. Razumovsky | Saratov | 410012 | Russia |
| LLC "Scientific Medical Center for General Therapy and Pharmacology" | Stavropol | 355000 | Russia |
| Tver State Medical University | Tver' | 170100 | Russia |
| Bashkir State Medical University, Internal Medicine Department | Ufa | 450008 | Russia |
| Voronezh Regional Clinical Hospital # 1 | Voronezh | 394066 | Russia |
| Central city hospital | Yaroslavl | 150040 | Russia |
| LLC "Medical Center for Diagnostics and Prevention Plus" | Yaroslavl | 150040 | Russia |
| Central city hospital # 7 | Yekaterinburg | 620137 | Russia |
| FG001 | Placebo | Tablet for oral use. Placebo: Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. Placebo is administered according to the Raphamin regimen. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Raphamin | Tablet for oral use. Raphamin: Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. On the first day, 8 tablets should be administered using the following regimen: 1 tablet every 30 minutes in the first 2 hours (5 tablets in total within 2 hours), then additionally one tablet 3 times with regular time intervals. From day 2 onwards, 1 tablet taken 3 times daily. The treatment period is 5 days. |
| BG001 | Placebo | Tablet for oral use. Placebo: Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. Placebo is administered according to the Raphamin regimen. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With COVID-19 Progression to a More Severe Form | Severity of COVID-19 is assessed in accordance with criteria presented in the current edition of the clinical recommendations of the Ministry of Health of the Russian Federation "Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19)". | Posted | Count of Participants | Participants | 28 days |
|
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| Secondary | Time to Sustained Clinical Recovery After New Coronavirus Disease COVID-19. | Sustained clinical recovery is a sustained improvement of clinical symptoms for at least 4 consecutive days. The day of improvement is considered the first of these 4 days. Criteria for improvement of clinical symptoms (according to the scoring system "Assessment of 14 Common COVID-19-Related Symptoms") are defined as follows:
| Posted | Mean | Standard Deviation | day | 28 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Hospitalized Patients | Based on the medical records. | Posted | Count of Participants | Participants | 28 days |
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| Other Pre-specified | Time to COVID-19 Progression to a More Severe Form | Severity of COVID-19 will be assessed in accordance with the criteria presented in the current edition of the clinical recommendations of the Ministry of Health of the Russian Federation "Prevention, diagnosis and treatment of a new coronavirus infection (COVID-19)". | Posted | Mean | Standard Deviation | day | 28 days |
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| Other Pre-specified | Percentage of Patients With Negative PCR Test for SARS-CoV-2 | Number of patients with a negative PCR test result for SARS-CoV-2 on days 6 and 10 of observation. Based on the medical records. | In accordance with protocol only PCR positive participants were analyzed | Posted | Count of Participants | Participants | On days 6 and 10 |
|
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| Other Pre-specified | Number of Participants With Adverse Events (AEs) | The presence of adverse events. Based on medical records. | Posted | Count of Participants | Participants | From day 1 to day 6 |
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| Other Pre-specified | Severity of AEs | The intensity (severity) of adverse events. Based on medical records. | Posted | Number | Number of AE | From day 1 to day 6 |
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| Other Pre-specified | Causal Relationship of AEs to the Sudy Drug | The causal relationship to the study drug of adverse events. Based on medical records. | Posted | Number | Number of AEs | From day 1 to day 6 |
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| Other Pre-specified | Outcome of AEs | The outcome of adverse events. Based on medical records. | Posted | Number | Number of AEs | From day 1 to day 6 |
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| Other Pre-specified | Changes in Vital Signs: Pulse Rate/Heart Rate in Beats Per Minute (Bpm) | The outcome measure is based on the medical records. The patient's heart rate (heart rate) is measured by the physician in visits 1, 3 and 4 (on days 1 and 6). | Posted | Mean | Standard Deviation | Bpm | On Visit 1 (day 1), Visit 3 (day 6), Visit 4 (day10) |
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| Other Pre-specified | Changes in Vital Signs: Respiration Rate/Breathing Rate in Breaths Per Minute | Outcome Measure is based on the medical records. The patient's respiration rate (breathing rate) is measured by physician in visits 1, 3 and 4 (on days 1 and 6). | Posted | Mean | Standard Deviation | Breaths per minute | On Visit 1 (day 1), Visit 3 (day 6), Visit 4 (day10) |
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| Other Pre-specified | Changes in Vital Signs: Capillary Blood Oxygen Saturation (SpO2) | Outcome Measure is based on the medical records. The patient's capillary blood oxygen saturation (SpO2) is measured by physician in visits 1, 3 and 4 (on days 1 and 6). | Posted | Mean | Standard Deviation | percentage of oxygen | On Visit 1 (day 1), Visit 3 (day 6), Visit 4 (day10) |
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| Other Pre-specified | Changes in Vital Signs: Blood Pressure in Units of Millimeters of Mercury (mmHg) | Outcome Measure is based on the medical records. The patient's blood pressure is measured by the physician in visits 1, 3 and 4 (on days 1 and 6). | Posted | Mean | Standard Deviation | mmHg | On Visit 1 (day 1), Visit 3 (day 6), Visit 4 (day10) |
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| Other Pre-specified | Percentage of Patients With Clinically Significant Abnormal Laboratory Tests | Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which are beyond the reference values at the end of treatment. | Posted | Count of Participants | Participants | On Visit 1 (day 1) and Visit 3 (day 6) |
|
|
Registration of AEs begins after the first dose of study drug and continues throughout the entire period of study therapy - 28 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Raphamin | Tablet for oral use. Raphamin: Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. On the first day, 8 tablets should be administered using the following regimen: 1 tablet every 30 minutes in the first 2 hours (5 tablets in total within 2 hours), then additionally one tablet 3 times with regular time intervals. From day 2 onwards, 1 tablet taken 3 times daily. The treatment period is 5 days. | 0 | 382 | 1 | 382 | 29 | 382 |
| EG001 | Placebo | Tablet for oral use. Placebo: Tablet for oral use. The drug is administered not during meals. The tablet should be held in mouth until complete dissolution. Placebo is administered according to the Raphamin regimen. | 0 | 389 | 0 | 389 | 46 | 389 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Worsening of persistent atrial fibrillation (symptoms of chest pain, palpitations, loss of consciousness from 22.11.2022). Hospitalized. |
|
| Complicated fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Closed, fragmented fracture of the fibula in the lower third of the left shin with displacement. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Without further clarification |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Without further clarification |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Exacerbation of hemorrhoids | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting urge | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bacterial prostatitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Maxillary sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dermatitis caused by herpes simplex virus | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Sinus infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paranasal sinus infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Exacerbation of chronic pyelonephritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Recurrent urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Etmoiditis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Protein in urine | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Presence of ketone bodies in urine | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abnormal Physical Examination Results | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abnormal blood count | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased blood pressure | Investigations | MedDRA (Unspecified) | Systematic Assessment | Without further clarification |
|
| Increased ALT | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased protein levels in urine | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased bilirubin | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased urinary glucose | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased creatinine | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased total bilirubin | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased C-reactive protein | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased transaminases | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased eosinophil count | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased neutrophil levels | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Low blood pressure | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decrease in general clinical blood test values | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematocrit reduction | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decrease in general bilirubin levels | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased platelet count | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased percentage of lymphocytes | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Decreased percentage of lymphocytes | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Without further clarification |
|
| Allergic reaction | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Generalized itching | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Itchy face | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Itching, cutaneous | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Itchy skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Increased sweating | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash on the face skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anemia unspecified | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | Without further clarification |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | Without further clarification |
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| Monocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Leg pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lumbar pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper limb myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute lumbago | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lumbar pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Without further clarification |
|
| Headache in the occipital region | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lumbar radicular pain | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tingling sensation in the eyelids | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Exacerbation of chronic cholecystitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Balanoposthitis | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Arterial hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| General malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Bruised finger | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director | MATERIA MEDICA HOLDING | +74952761571 | 302 | PutilovskiyMA@materiamedica.ru |
| Feb 13, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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