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| Name | Class |
|---|---|
| Amarex Clinical Research | OTHER |
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The purpose of this study is to assess the efficacy and safety of Ampligen® administered twice weekly by intravenous (IV) infusions in subjects experiencing the Post-COVID Condition of fatigue.
This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the efficacy and safety of Ampligen® in patients experiencing the Post-COVID Condition of fatigue. Patients will be randomized 1:1 to receive twice weekly IV infusions of Ampligen® or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ampligen / rintatolimod | Experimental | Subjects will receive rintatolimod (intravenous [IV]), up to 400 mg twice weekly for 12 weeks. |
|
| Placebo / Saline | Placebo Comparator | Subjects will receive placebo / normal saline (intravenous [IV]), up to 160 mL twice weekly for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rintatolimod | Drug | 100 to 400 mg twice weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score) | Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue. | Baseline and Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 in PROMIS Fatigue Score (T-Score) | Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. | The SBQ-LC (Symptom Burden Questionnaire for Long COVID), which includes questions related to common COVID-19 symptoms, was assessed at baseline and at every odd-numbered visit from Visit 3 to Visit 25. Data at baseline and change from baseline at Week 12 (end of treatment) is reported. The converted scores reported for each symptom range from 0 to 100, with a higher score indicating worse symptom burden. |
Inclusion Criteria:
Male or female adult between 18 to 60 (inclusive) years of age at time of enrollment.
Prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing at least 12 weeks prior to baseline.
Note: For subjects with COVID-19 symptoms who were not tested for the presence of SARS-CoV-2, a positive serum antibody test for SARS-CoV-2 will be sufficient in subjects not vaccinated for COVID-19 or it can be shown that the positive antibody cannot be associated with the COVID-19 vaccination.
Laboratory confirmed negative SARS-CoV-2 (COVID-19) infection by a government approved test / kit at time of enrollment.
Subject meets the criteria of fatigue per the 1994 CDC Case Definition for Chronic Fatigue Syndrome (CFS): Unexplained persistent or relapsing chronic fatigue that is of new or definite onset (i.e., not lifelong), is not the result of ongoing exertion, is not substantially alleviated by rest, and results in substantial reduction in previous levels of occupational, educational, social, or personal activities. The fatigue must have persisted or recurred during 3 or more consecutive months of illness and must not have preceded the onset of the COVID-19 symptoms.
PROMIS® Fatigue- Short Form 7a score of ≥21 at screening and baseline.
Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator.
Note: Below are the examples of clinically significant ECG abnormalities:
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Men and women of childbearing potential and their partner must agree to use two medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or one of the following methods of birth control (intrauterine devices, bilateral tubal occlusion, or vasectomy) or must practice complete sexual abstinence for the duration of the study (excluding women who are not of childbearing potential and men who have been sterilized).
Females of child-bearing potential must have a negative urine pregnancy test at Screening Visit and prior to receiving the first dose of study drug; and Male participants must agree to use contraception and refrain from donating sperm for at least 90 days after the last dose of study intervention.
Subject is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures and study restrictions.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Strayer, MD | AIM ImmunoTech Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Clinical Research | Canoga Park | California | 91303 | United States | ||
| 310 Clinical Research |
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Of 142 screened participants, 80 met inclusion criteria and were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ampligen / Rintatolimod | Subjects received rintatolimod (intravenous [IV]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly |
| FG001 | Placebo / Saline | Subjects received placebo / normal saline (intravenous [IV]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Total of 80 subjects were enrolled. Forty were randomized to each study group (Ampligen® or placebo). All subjects received at least one treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ampligen® /Rintatolimod | Subjects received rintatolimod (intravenous [IV]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly |
| BG001 | Placebo/Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Adult between 18 to 60 (inclusive)years of age at time of enrollment |
| 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 | Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score) | Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue. | The Modified Intent-to-Treat (mITT) Population defined as the set of subjects who received at least one dose of study treatment (Ampligen® or placebo). | Posted | Mean | Standard Deviation | T-Score | Baseline and Week 13 |
|
14 weeks
AEs reported through direct questioning and subject reports. An AE is defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient to have occurred, or the worsening of a pre-existing condition. Any abnormality in physical examination findings or laboratory results that the investigator believes is clinically significant (CS) to the research subject and that occurred after initiation of the first study treatment were reported as AEs.
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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 | Ampligen / Rintatolimod | Subjects received rintatolimod (intravenous [IV]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
Study didn't aim to establish statistical significance of Ampligen® over placebo. Sample size of 80 subjects was based on clinical judgement and no statistical power calculation was used. Fatigue itself, along with cognitive function and sleep, is a multidimensional measure and can be influenced by many factors beyond study treatment, such as general health status, physical activity, etc. Placebo effect is a known challenge, particularly when using patient-reported outcomes as study endpoints.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diane Young | AIM ImmunoTech Inc. | 352-448-7797 | diane.young@aimimmuno.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2023 | Nov 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2023 | Nov 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| C047490 | poly(I).poly(c12,U) |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo / Normal Saline | Other | 40 to 160 mL twice weekly |
|
| Baseline to Week 6 |
| Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven | Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. For this endpoint, the last question of "How often did you have enough energy to exercise strenuously" was excluded. Therefore, the lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 33.4; the highest possible T-score is 76.8. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. | Baseline to Week 6 and 13 |
| Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) | The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. | Baseline to week 6 and week 13 |
| Percentage of Subjects With Minimal Clinically Important Difference (MCID) | Percentage of subjects with increase of at least 54 m from baseline in the Six-Minute Walk Test (6MWT) at the end of 12-week treatment phase presented and summarized descriptively by treatment group. | End of 12 week treatment phase |
| Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score). | Change in mean cognitive function T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Cognitive Function - Abilities short form 8a that assesses self-perceived cognitive deficits. The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 23.27; the highest possible T-score is 67.09. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the better the cognitive function of the individual. Scores >45 are within normal limits, 40-45 mild, 30-40 moderate, and <30 severe cognitive dysfunction. | Baseline to Week 6 and 13 |
| Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score) | Change in mean sleep disturbance T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance - short form 4a that assesses self-perceived sleep quality. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 32; the highest possible T-score is 73.3. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the sleep disturbance of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue. | Baseline to Week 6 and 13 |
| Baseline and the end of treatment phase at week 12 |
| Change From Baseline in Cognitive Function as Measured by Montreal Cognitive Assessment (MoCA) at Weeks 4, 8, and 13 During the Treatment Phase | The change from baseline in Montreal Cognitive Assessment (MoCA) at week 4, 8, and 13 is presented and summarized descriptively by treatment group. Higher scores indicate better cognitive function; total scores equal to or higher than 26 are considered normal. Montreal Cognitive Assessment range is from 0-30, with a score of 26 or higher indicating normal cognitive function. 18-25 indicates mild cognitive impairment; 10-17 indicates moderate cognitive impairment; less than 10 indicates severe cognitive impairment. | Baseline to weeks 4, 8 and 13 during treatment phase |
| Hospitalizations | Number of subjects with hospitalization during treatment phase up to week 12. | During the treatment phase up to 12 weeks |
| Duration of Hospitalizations | Duration (days) of hospitalization during the treatment phase up to week 12. | During the treatment phase up to 12 weeks |
| Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3+ | A blood sample was collected at V2 (pre-dose), V12 (pre-dose), and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of lymphocyte profile by flow cytometry. The absolute values and change from baseline data for CD3+ were evaluated. | Baseline to week 6 and 13 |
| Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3-CD56+ Natural Kill | A blood sample was collected at V2 (pre-dose), V12 (pre-dose), and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of lymphocyte profile by flow cytometry. The absolute values and change from baseline data for CD3-CD56+ natural killers (NK+) were evaluated. | Baseline to week 6 and 13 |
| Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - CD4:CD8 Ratio | A blood sample was collected at V2 (pre-dose), V12 (pre-dose), and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of lymphocyte profile by flow cytometry. The absolute values and change from baseline data for CD4:CD8 ratio were evaluated. | Baseline to week 6 and 13 |
| Identification and Evaluation of Plasma Protein Biomarkers in Patients With Post-COVID-19 Conditions | A blood sample was collected at V2 (pre-dose) and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of protein biomarkers. | Baseline and week 13 |
| Inglewood |
| California |
| 90301 |
| United States |
| Acclaim Clinical Research | San Diego | California | 92120 | United States |
| Alfa Medical Research | Davie | Florida | 33024 | United States |
| Zenos Clinical Research | Dallas | Texas | 75230 | United States |
| Withdrawal by Subject |
|
Subjects received placebo / normal saline (intravenous [IV]), up to 160 mL twice weekly for 12 weeks.
Placebo / Normal Saline: 40 to 160 mL twice weekly
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Hispanic or Latino Not Hispanic or Latino | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height (cm) | At screening visit Height of subjects in cm were collected. | Mean | Standard Deviation | cm |
|
| Weight (kg) | Weight of subjects in kg were collected. | Mean | Standard Deviation | kg |
|
| BMI (kg/m^2) | BMI (kg/m^2) = Weight (kg)/[Height (cm)/100]^2 | Mean | Standard Deviation | kg/m^2 |
|
| OG000 | Ampligen / Rintatolimod | Subjects received rintatolimod (intravenous [IV]), up to 400 mg twice weekly for 12 weeks. Rintatolimod: 100 to 400 mg twice weekly |
| OG001 | Placebo / Saline | Subjects received placebo / normal saline (intravenous [IV]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly |
|
|
|
| Secondary | Change From Baseline to Week 6 in PROMIS Fatigue Score (T-Score) | Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. The lowest possible raw score is 7; the highest possible raw score is 35. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 29.4; the highest possible T-score is 83.2. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue. | The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo). | Posted | Mean | Standard Deviation | T-Score | Baseline to Week 6 |
|
|
|
|
| Secondary | Change From Baseline to Week 13 in PROMIS Fatigue Score (T-Score), Excluding Response to Item Seven | Change in mean fatigue T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Fatigue short form 7a that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to extreme exhaustion. For this endpoint, the last question of "How often did you have enough energy to exercise strenuously" was excluded. Therefore, the lowest possible raw score is 6; the highest possible raw score is 30. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 33.4; the highest possible T-score is 76.8. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the fatigue of the individual. | The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo). | Posted | Mean | Standard Deviation | T-Score | Baseline to Week 6 and 13 |
|
|
|
|
| Secondary | Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) | The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. | The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo). | Posted | Mean | Standard Deviation | Meters | Baseline to week 6 and week 13 |
|
|
|
|
| Secondary | Percentage of Subjects With Minimal Clinically Important Difference (MCID) | Percentage of subjects with increase of at least 54 m from baseline in the Six-Minute Walk Test (6MWT) at the end of 12-week treatment phase presented and summarized descriptively by treatment group. | The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo). | Posted | Count of Participants | Participants | End of 12 week treatment phase |
|
|
|
|
| Secondary | Change From Baseline to Week 6 and 13 in PROMIS Cognitive Function Converted Score (T-Score). | Change in mean cognitive function T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Cognitive Function - Abilities short form 8a that assesses self-perceived cognitive deficits. The lowest possible raw score is 8; the highest possible raw score is 40. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 23.27; the highest possible T-score is 67.09. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the better the cognitive function of the individual. Scores >45 are within normal limits, 40-45 mild, 30-40 moderate, and <30 severe cognitive dysfunction. | The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo). | Posted | Mean | Standard Deviation | T-Score | Baseline to Week 6 and 13 |
|
|
|
|
| Secondary | Change From Baseline to Week 6 and 13 in PROMIS Sleep Disturbance Score (T-Score) | Change in mean sleep disturbance T-score as measured by PROMIS® (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance - short form 4a that assesses self-perceived sleep quality. The lowest possible raw score is 4; the highest possible raw score is 20. Raw summed scores are converted to T-score values that are standardized such that 50 represents the average (mean) for the US general population, with a standard deviation of 10 points. The lowest possible T-score is 32; the highest possible T-score is 73.3. A higher T-score represents more of the concept being measured, meaning the higher the T-Score, the worse the sleep disturbance of the individual. Scores <55 are within normal limits, 55-60 mild, 61-70 moderate, and >70 severe fatigue. | All Modified Intent to Treat (mITT) Population | Posted | Mean | Standard Deviation | T-Score | Baseline to Week 6 and 13 |
|
|
|
|
| Other Pre-specified | Changes From Baseline in COVID-19-related Symptoms Using Symptom Burden Questionnaire for Long COVID (SBQ-LC) During the Course of the Treatment Phase. | The SBQ-LC (Symptom Burden Questionnaire for Long COVID), which includes questions related to common COVID-19 symptoms, was assessed at baseline and at every odd-numbered visit from Visit 3 to Visit 25. Data at baseline and change from baseline at Week 12 (end of treatment) is reported. The converted scores reported for each symptom range from 0 to 100, with a higher score indicating worse symptom burden. | The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo). | Posted | Mean | Standard Deviation | units on a scale | Baseline and the end of treatment phase at week 12 |
|
|
|
| Other Pre-specified | Change From Baseline in Cognitive Function as Measured by Montreal Cognitive Assessment (MoCA) at Weeks 4, 8, and 13 During the Treatment Phase | The change from baseline in Montreal Cognitive Assessment (MoCA) at week 4, 8, and 13 is presented and summarized descriptively by treatment group. Higher scores indicate better cognitive function; total scores equal to or higher than 26 are considered normal. Montreal Cognitive Assessment range is from 0-30, with a score of 26 or higher indicating normal cognitive function. 18-25 indicates mild cognitive impairment; 10-17 indicates moderate cognitive impairment; less than 10 indicates severe cognitive impairment. | The Modified Intent-to-Treat (mITT) population is defined as the set of subjects whohave received at least one dose of study treatment (Ampligen® or placebo). | Posted | Mean | Standard Deviation | score on a scale | Baseline to weeks 4, 8 and 13 during treatment phase |
|
|
|
|
| Other Pre-specified | Hospitalizations | Number of subjects with hospitalization during treatment phase up to week 12. | all Modified Intent-to-Treat population subjects | Posted | Number | participants | During the treatment phase up to 12 weeks |
|
|
|
|
| Other Pre-specified | Duration of Hospitalizations | Duration (days) of hospitalization during the treatment phase up to week 12. | No patients were hospitalized. | Posted | During the treatment phase up to 12 weeks |
|
|
| Other Pre-specified | Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3+ | A blood sample was collected at V2 (pre-dose), V12 (pre-dose), and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of lymphocyte profile by flow cytometry. The absolute values and change from baseline data for CD3+ were evaluated. | all Modified Intent-to-Treat population subjects | Posted | Mean | Standard Deviation | CD3+ cells/μL | Baseline to week 6 and 13 |
|
|
|
|
| Other Pre-specified | Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - Absolute Value of CD3-CD56+ Natural Kill | A blood sample was collected at V2 (pre-dose), V12 (pre-dose), and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of lymphocyte profile by flow cytometry. The absolute values and change from baseline data for CD3-CD56+ natural killers (NK+) were evaluated. | all Modified Intent-to-Treat population subjects | Posted | Mean | Standard Deviation | CD3-CD56+ Natural Killer cells/μL | Baseline to week 6 and 13 |
|
|
|
|
| Other Pre-specified | Evaluation of Lymphocyte Profile by Flow Cytometry in Patients With Post-COVID-19 Conditions - CD4:CD8 Ratio | A blood sample was collected at V2 (pre-dose), V12 (pre-dose), and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of lymphocyte profile by flow cytometry. The absolute values and change from baseline data for CD4:CD8 ratio were evaluated. | all Modified Intent-to-Treat population subjects | Posted | Mean | Standard Deviation | CD4:CD8 Ratio | Baseline to week 6 and 13 |
|
|
|
|
| Other Pre-specified | Identification and Evaluation of Plasma Protein Biomarkers in Patients With Post-COVID-19 Conditions | A blood sample was collected at V2 (pre-dose) and V26 (Follow-up 1) for research purposes to conduct exploratory analyses of protein biomarkers. | Not Posted | Baseline and week 13 | Participants |
| Post-Hoc | Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) - Subjects Walking ≥205 Meters at Baseline | The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. | The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo). | Posted | Mean | Standard Deviation | Meters | Baseline to week 6 and week 13 |
|
|
|
|
| Post-Hoc | Change From Baseline to Week 6 and Week 13 in Distance Traveled During 6-minute Walk Test (6MWT) - Subjects Walking <205 Meters at Baseline | The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. | The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of study treatment (Ampligen® or placebo). | Posted | Mean | Standard Deviation | Meters | Baseline to week 6 and week 13 |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 10 |
| 40 |
| EG001 | Placebo / Saline | Subjects received placebo / normal saline (intravenous [IV]), up to 160 mL twice weekly for 12 weeks. Placebo / Normal Saline: 40 to 160 mL twice weekly | 0 | 40 | 0 | 40 | 4 | 40 |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Paraesthesia | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Injection site phlebitis | General disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version 25.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA Version 25.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA Version 25.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Peripheral coldness | Vascular disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Eustachian tube obstruction | Ear and labyrinth disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | Systematic Assessment |
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Not provided
| 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 |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| change from baseline at week6-V12 |
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| change from baseline at Week6-V12 |
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| change from baseline at Week13-V26 |
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| Change from baseline at week6-V12 |
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| Change from baseline at week13-V26 |
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| Change from Baseline to week6-V12 |
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| Change from baseline to week13-V26 |
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| Change from baseline at Week6-V12 |
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| change from baseline at Week13-V26 |
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| Mean change from baseline at week12 : Breathing |
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| Baseline : Circulation |
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| Mean change from baseline at week12 : Circulation |
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| Baseline : Ear, Nose, and Throat |
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| Mean change from baseline at week12 : Ear, Nose, and Throat |
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| Baseline: Eyes |
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| change from baseline to week12 : Eyes |
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| Baseline Fatigue converted score |
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| change from baseline at week12 for fatigue score |
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| Baseline: Female Repro.& Sex Health |
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| change from baseline at week 12; Female Repro.& Sex Health |
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| Baseline: Impact on Daily Life Scale |
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| Baseline:Male Repro.&Sex Health |
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| change from baseline at week 12: Male Reproductive and Sexual Health |
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| Baseline: Memory,Thinking&Commun. |
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| Change from baseline to week 12; Memory,Thinking&Commun. |
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| Baseline: MentalHealth & Wellbeing |
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| Baseline: Movement |
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| Change from baseline at week 12: Movement |
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| Baseline: Muscle & Joints |
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| change from baseline at week 12: Muscle & Joints |
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| Baseline: Other Symptoms |
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| Change from baseline at week 12: Other Symptoms |
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| Baseline: Pain Scale |
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| Change from Baseline at week12: Pain Scale |
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| Baseline: Skin & Hair |
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| Baseline: Sleep Scale |
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| Change from Baseline at week12: Sleep Scale |
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| Baseline: Stomach & Digestion |
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| Change from Baseline: Stomach & Digestion |
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| change from baseline at Week 4 - V8 |
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| change from baseline at Week 8 - v16 |
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| change from baseline at Week 13 - V26 |
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| Change from Baseline to Week6-V12 |
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| Change from Baseline to Week13-V26 |
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| Change from Baseline to Week6-V12 |
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| Change from Baseline to Week13-V26 |
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| Change from Baseline to Week6-V12 |
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| Change from Baseline to Week13-V26 |
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| Change from baseline at week6-V12 |
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| Change from baseline at week13-V26 |
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| Change from baseline at week13-V26 |
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