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A Clinical Evaluation of the Safety and Efficacy of Randomized Placebo Versus the 8-aminoquinoline Tafenoquine for Early Symptom Resolution in Patients With Mild to Moderate COVID 19 Disease and Low Risk of Disease Progression

Primary Purpose

COVID 19 Disease, Mild to Moderate COVID 19 Disease, SARS-CoV-2

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tafenoquine Oral Tablet
Placebo
Sponsored by
60P Australia Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID 19 Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, aged ≥18, regardless of COVID-19 vaccination status; Laboratory confirmed infection COVID-19 disease as determined using an FDA-authorized COVID-19 rapid antigen test; Able and willing to give written informed consent; Willing to complete the following study activities and assessments: Keep an electronic diary from Study Days 2 through 42. Have phone or videoconferences with study team personnel on Study Days 10, 21, and 35. Have study samples collected in-home on Days 5, 14, 28, and 42 Agree to return to clinic for additional safety evaluations if needed, as determined by the study team; An aggregate patient-reported COVID-19 symptom score of at ≥3 on the first day of drug administration (Study Day 1). Must agree not to enroll in another study of an investigational agent prior to completion of Day 42 of the study; Able to take ARAKODA according to Prescribing Information Have been symptomatic no longer than 7 days inclusive of Day 1 when the first dose of study medication is administered. If female, agree to use an acceptable method of birth control from the time of consent through 56 days after the last dose of study drug. Possess a smart phone or tablet, or are willing to utilize a sponsor-provided device if available. Exclusion Criteria: Have any of the contraindications for ARAKODA in the prescribing information including: G6PD deficiency Breastfeeding Psychotic disorder or current psychotic symptoms Known hypersensitivity reaction to TQ Evidence of severe or critical illness, defined by at least one of the following: Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room air Respiratory failure defined based on resource utilization requiring at least one of the following: i. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); ii. Shock (defined by systolic blood pressure <90 mmHg, or diastolic blood pressure <60 mmHg or requiring vasopressors); iii. Multi-organ dysfunction/failure Any other clinically significant acute illness unrelated to COVID-19 within seven days prior to first study drug administration; Receipt of any approved or experimental small molecule treatment for COVID-19 (FDA-approved, off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation Receipt of any approved or experimental biologic therapeutic for COVID-19 (FDA-approved, off-label, compassionate use, or study-related) within the 90 days prior to the time of the screening evaluation Have been diagnosed (and confirmed by PCR or rapid antigen test) with COVID-19 in the 90 days prior to randomization (other than for this infection); Any excluded concomitant medication as described in the ARAKODA package insert. Receipt of a COVID-19 vaccine is not exclusionary; Any COVID-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment. Positive pregnancy test; Are ≥65 years of age and have a clinical frailty score > 5; Have cystic fibrosis; Have received a transplant; Known to be infected with human immunodeficiency virus (HIV); Have received any B-Cell depleting monoclonal antibody in the last six months; Have a disease or condition which in the opinion of the investigator presents an unacceptable risk of disease progression; Have an aggregate symptom score ≥ 15 and any one of the following risk factors for COVID-19 disease progression: Obesity (BMI ≥31), are a smoker, have never been vaccinated for COVID-19, diabetes with complications, dementia or other neurocognitive disorders, chronic kidney disease, chronic liver disease, COPD or other chronic lung disease, bronchiectasis, coronary atherosclerosis and other heart disease, stroke or other cerebrovascular disease, sickle cell disease or thalassemia, current mood disorder or depression, substance abuse disorder, tuberculosis, cancer that is not invasive squamous and basal carcinomas of the skin or prostate cancer under active surveillance; Have two or more of the following risk factors for COVID-19 disease progression: Obesity (BMI ≥31), are a smoker, diabetes with complications, dementia or other neurocognitive disorders, chronic kidney disease, chronic liver disease, COPD or other chronic lung disease, bronchiectasis, coronary atherosclerosis and other heart disease, stroke or other cerebrovascular disease, sickle cell disease or thalassemia, current mood disorder or depression, substance abuse disorder, tuberculosis, cancer that is not invasive squamous and basal carcinomas of the skin or prostate cancer under active surveillance; Have an aggregate symptom score >32.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tafenoquine

    Placebo

    Arm Description

    Tafenoquine two tablets 1x/day on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery

    Placebo two tablets 1x/day on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery

    Outcomes

    Primary Outcome Measures

    Time to sustained clinical recovery from COVID-19 symptoms (4 uninterrupted days of aggregate symptom scores ≤ 2) through Day 28 (± 2 days)

    Secondary Outcome Measures

    MCP-1 levels at Days 5, 14 (± 1 day) and 28 (± 2 days)
    Day 5 aggregate symptom score (FDA's 14 COVID-19 symptoms)
    Time to clinical resolution (uninterrupted daily aggregate symptom score ≤ 2 for at least 1, 2 or 3 occasions) of all COVID-19 symptoms through Day 28 (± 2 days)
    Time to sustained clinical resolution (uninterrupted daily aggregate symptom score ≤ 2 for at least 1, 2, 3, or 4 occasions) of all COVID-19 symptoms through Days 14 (± 1 day) and 42 (± 2 days)
    Proportion of patients with sustained clinical resolution (uninterrupted daily aggregate symptom score ≤ 2 on at least 1, 2, or 3 or 4 occasions) of all COVID-19 symptoms at Days 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
    Time to first instance of clinical recovery from fever, cough, and shortness of breath at 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days) who reported at least one such symptom on Day 1 (recovery defined as in Dow and Smith 2022)
    Proportion of patients recovered (first instance) from cough, fever, and shortness of breath at Day 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days) who reported at least one such symptom on Day 1 (recovery defined as in Dow and Smith 2022)
    Time to sustained recovery (two, three or four uninterrupted days of recovery) from fever, cough, and shortness of breath at 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days) who reported at least one such symptom on Day 1
    Proportion of patients recovered (sustained recovery for two, three or four uninterrupted days) from cough, fever, and shortness of breath at Day 14 (± 1 day), Day 28 (± 1 day) and 42 (± 2 days) who reported at least one such symptom on Day 1

    Full Information

    First Posted
    July 13, 2023
    Last Updated
    July 13, 2023
    Sponsor
    60P Australia Pty Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05947812
    Brief Title
    A Clinical Evaluation of the Safety and Efficacy of Randomized Placebo Versus the 8-aminoquinoline Tafenoquine for Early Symptom Resolution in Patients With Mild to Moderate COVID 19 Disease and Low Risk of Disease Progression
    Official Title
    A Clinical Evaluation of the Safety and Efficacy of Randomized Placebo Versus the 8-aminoquinoline Tafenoquine for Early Symptom Resolution in Patients With Mild to Moderate COVID 19 Disease and Low Risk of Disease Progression (the "ACLR8-LR" Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    April 27, 2024 (Anticipated)
    Study Completion Date
    April 27, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    60P Australia Pty Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A clinical study to assess the efficacy and safety of oral tafenoquine compared to placebo in patients with mild to moderate COVID 19 disease and low risk of disease progression (the "ACLR8-LR" study).
    Detailed Description
    The TQ 2020_08 study is a double-blind placebo-controlled, Phase 2b clinical trial that plans to enroll approximately 148 non-hospitalized patients with mild to moderate COVID 19 disease and low risk of disease progression (the "ACLR8-LR" study). Patients will undergo a brief screening period before being randomized to receive either self-administered 200 mg tafenoquine or matching placebo for up to 38 days. Following the treatment period, patients will have a follow up visit at study Day 42. The study's primary efficacy endpoint is time to sustained clinical recovery from COVID-19 symptoms (4 uninterrupted days of aggregate symptom scores ≤ 2) through Day 28 (± 2 days).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID 19 Disease, Mild to Moderate COVID 19 Disease, SARS-CoV-2, Infectious Disease, Severe Acute Respiratory Syndrome Coronavirus 2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    148 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tafenoquine
    Arm Type
    Experimental
    Arm Description
    Tafenoquine two tablets 1x/day on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo two tablets 1x/day on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery
    Intervention Type
    Drug
    Intervention Name(s)
    Tafenoquine Oral Tablet
    Other Intervention Name(s)
    KODATEF™, Arakoda
    Intervention Description
    Patients will be randomized and will receive and self-administer 200 mg Tafenoquine on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and then weekly (Days 10 ± 1 day, 17 ± 2 days, 24 ± 2 days, 31 ± 2 days and 38 ± 2 days) until sustained clinical recovery.
    Primary Outcome Measure Information:
    Title
    Time to sustained clinical recovery from COVID-19 symptoms (4 uninterrupted days of aggregate symptom scores ≤ 2) through Day 28 (± 2 days)
    Time Frame
    Day 28 (± 2 days)
    Secondary Outcome Measure Information:
    Title
    MCP-1 levels at Days 5, 14 (± 1 day) and 28 (± 2 days)
    Time Frame
    Days 5, 14 (± 1 day) and 28 (± 2 days)
    Title
    Day 5 aggregate symptom score (FDA's 14 COVID-19 symptoms)
    Time Frame
    Day 5
    Title
    Time to clinical resolution (uninterrupted daily aggregate symptom score ≤ 2 for at least 1, 2 or 3 occasions) of all COVID-19 symptoms through Day 28 (± 2 days)
    Time Frame
    Day 28 (± 2 days)
    Title
    Time to sustained clinical resolution (uninterrupted daily aggregate symptom score ≤ 2 for at least 1, 2, 3, or 4 occasions) of all COVID-19 symptoms through Days 14 (± 1 day) and 42 (± 2 days)
    Time Frame
    Days 14 (± 1 day) and 42 (± 2 days)
    Title
    Proportion of patients with sustained clinical resolution (uninterrupted daily aggregate symptom score ≤ 2 on at least 1, 2, or 3 or 4 occasions) of all COVID-19 symptoms at Days 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
    Time Frame
    Days 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
    Title
    Time to first instance of clinical recovery from fever, cough, and shortness of breath at 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days) who reported at least one such symptom on Day 1 (recovery defined as in Dow and Smith 2022)
    Time Frame
    14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
    Title
    Proportion of patients recovered (first instance) from cough, fever, and shortness of breath at Day 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days) who reported at least one such symptom on Day 1 (recovery defined as in Dow and Smith 2022)
    Time Frame
    Day 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
    Title
    Time to sustained recovery (two, three or four uninterrupted days of recovery) from fever, cough, and shortness of breath at 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days) who reported at least one such symptom on Day 1
    Time Frame
    14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
    Title
    Proportion of patients recovered (sustained recovery for two, three or four uninterrupted days) from cough, fever, and shortness of breath at Day 14 (± 1 day), Day 28 (± 1 day) and 42 (± 2 days) who reported at least one such symptom on Day 1
    Time Frame
    Day 14 (± 1 day), Day 28 (± 1 day) and 42 (± 2 days)
    Other Pre-specified Outcome Measures:
    Title
    Proportion of patients with negative COVID-19 rapid antigen test at Day 7 (± 1 day) and at first report after day 3 of feeling able to resume normal activities (± 1 days)
    Time Frame
    Day 7 (± 1 day) and at first report after day 3 of feeling able to resume normal activities (± 1 days)
    Title
    Clinical relapse through Day 42 (± 2 days) of COVID symptoms defined as at least three days of aggregate symptoms score > 2 after achieving clinical recovery for the primary endpoint
    Time Frame
    Day 42 (± 2 days)
    Title
    Time to first report by the patient that they can resume normal activities
    Time Frame
    Time to first report by the patient
    Title
    Time to first report by the patient that they feel recovered from COVID-19 symptoms
    Time Frame
    Time to first report by the patient
    Title
    Cytokine and chemokine levels at Screening, Day 5, Day 14 (± 1 day) and Day 28 (± 2 days)
    Time Frame
    Screening, Day 5, Day 14 (± 1 day) and Day 28 (± 2 days)
    Title
    Total anti-SARS-CoV-2 spike protein antibody levels (IgM and IgG) at Screening and Day 14 (± 1 day)
    Time Frame
    Screening and Day 14 (± 1 day)
    Title
    Hospitalization rates due to COVID-19 symptoms (excluding non-COVID 19 causes including admittance for other upper respiratory infections and admittance only for administrative or observations purposes)
    Time Frame
    Day 42 (± 2 days)
    Title
    Number of unscheduled COVID-19-related medical visits (Doctor's office or emergency room (ER) visit)
    Time Frame
    Day 42 (± 2 days)
    Title
    Incidence of COVID-19 related neuropsychiatric symptoms (depression, anxiety, impaired wakefulness, memory or ability thinking)
    Time Frame
    Incidence of COVID-19 related neuropsychiatric symptoms
    Title
    Time to first instance of and sustained recovery from "Long Covid" symptoms individually and together
    Time Frame
    Time to first instance of and sustained recovery
    Title
    Proportion of patients recovered from "Long Covid" symptoms individually and together at Days 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)
    Time Frame
    Days 14 (± 1 day), 28 (± 2 days) and 42 (± 2 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, aged ≥18, regardless of COVID-19 vaccination status; Laboratory confirmed infection COVID-19 disease as determined using an FDA-authorized COVID-19 rapid antigen test; Able and willing to give written informed consent; Willing to complete the following study activities and assessments: Keep an electronic diary from Study Days 2 through 42. Have phone or videoconferences with study team personnel on Study Days 10, 21, and 35. Have study samples collected in-home on Days 5, 14, 28, and 42 Agree to return to clinic for additional safety evaluations if needed, as determined by the study team; An aggregate patient-reported COVID-19 symptom score of at ≥3 on the first day of drug administration (Study Day 1). Must agree not to enroll in another study of an investigational agent prior to completion of Day 42 of the study; Able to take ARAKODA according to Prescribing Information Have been symptomatic no longer than 7 days inclusive of Day 1 when the first dose of study medication is administered. If female, agree to use an acceptable method of birth control from the time of consent through 56 days after the last dose of study drug. Possess a smart phone or tablet, or are willing to utilize a sponsor-provided device if available. Exclusion Criteria: Have any of the contraindications for ARAKODA in the prescribing information including: G6PD deficiency Breastfeeding Psychotic disorder or current psychotic symptoms Known hypersensitivity reaction to TQ Evidence of severe or critical illness, defined by at least one of the following: Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥30 breaths per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room air Respiratory failure defined based on resource utilization requiring at least one of the following: i. Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); ii. Shock (defined by systolic blood pressure <90 mmHg, or diastolic blood pressure <60 mmHg or requiring vasopressors); iii. Multi-organ dysfunction/failure Any other clinically significant acute illness unrelated to COVID-19 within seven days prior to first study drug administration; Receipt of any approved or experimental small molecule treatment for COVID-19 (FDA-approved, off-label, compassionate use, or study-related) within the 30 days prior to the time of the screening evaluation Receipt of any approved or experimental biologic therapeutic for COVID-19 (FDA-approved, off-label, compassionate use, or study-related) within the 90 days prior to the time of the screening evaluation Have been diagnosed (and confirmed by PCR or rapid antigen test) with COVID-19 in the 90 days prior to randomization (other than for this infection); Any excluded concomitant medication as described in the ARAKODA package insert. Receipt of a COVID-19 vaccine is not exclusionary; Any COVID-19 symptoms which, in the opinion of the investigator, is suggestive of possible requirement to hospitalize within 48 hours of enrollment. Positive pregnancy test; Are ≥65 years of age and have a clinical frailty score > 5; Have cystic fibrosis; Have received a transplant; Known to be infected with human immunodeficiency virus (HIV); Have received any B-Cell depleting monoclonal antibody in the last six months; Have a disease or condition which in the opinion of the investigator presents an unacceptable risk of disease progression; Have an aggregate symptom score ≥ 15 and any one of the following risk factors for COVID-19 disease progression: Obesity (BMI ≥31), are a smoker, have never been vaccinated for COVID-19, diabetes with complications, dementia or other neurocognitive disorders, chronic kidney disease, chronic liver disease, COPD or other chronic lung disease, bronchiectasis, coronary atherosclerosis and other heart disease, stroke or other cerebrovascular disease, sickle cell disease or thalassemia, current mood disorder or depression, substance abuse disorder, tuberculosis, cancer that is not invasive squamous and basal carcinomas of the skin or prostate cancer under active surveillance; Have two or more of the following risk factors for COVID-19 disease progression: Obesity (BMI ≥31), are a smoker, diabetes with complications, dementia or other neurocognitive disorders, chronic kidney disease, chronic liver disease, COPD or other chronic lung disease, bronchiectasis, coronary atherosclerosis and other heart disease, stroke or other cerebrovascular disease, sickle cell disease or thalassemia, current mood disorder or depression, substance abuse disorder, tuberculosis, cancer that is not invasive squamous and basal carcinomas of the skin or prostate cancer under active surveillance; Have an aggregate symptom score >32.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Geoff Dow, PhD
    Phone
    202-327-5422
    Email
    geoffdow@60degreespharma.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    Citation
    60º Pharmaceuticals LLC. Clinical Study Report, TQ 2020_06. A double-blind placebo-controlled study to assess the efficacy and safety of oral tafenoquine versus placebo in patients with mild to moderate COVID-19 disease. 14 July 2022
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    Bobrowski T, Chen L, Eastman RT, Itkin Z, Shinn P, Chen CZ, Guo H, Zheng W, Michael S, Simeonov A, Hall MD, Zakharov AV, Muratov EN. Synergistic and Antagonistic Drug Combinations against SARS-CoV-2. Mol Ther. 2021 Feb 3;29(2):873-885. doi: 10.1016/j.ymthe.2020.12.016. Epub 2020 Dec 15.
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    Brueckner RP, Lasseter KC, Lin ET, Schuster BG. First-time-in-humans safety and pharmacokinetics of WR 238605, a new antimalarial. Am J Trop Med Hyg. 1998 May;58(5):645-9. doi: 10.4269/ajtmh.1998.58.645.
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    Dow GS, Luttick A, Fenner J, Wesche D, Yeo KR, Rayner C. Tafenoquine inhibits replication of SARS-CoV-2 at pharmacologically relevant cincentrations in vitro. Biorxiv; Tafenoquine inhibits replication of SARS-Cov-2 at pharmacologically relevant concentrations in vitro. bioRxiv.2020. https://doi.org/10.1101/2020.07.12.199059
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    Dow GS, Smith BL. A phase II, double blind, placebo-controlled, randomized evaluation of the safety and efficacy of tafenoquine in patients with mild-moderate COVID-19 disease. New Microbes New Infect. 2022 Jun 1;47:100986. doi: 10.1016/j.nmni.2022.100986. eCollection 2022 Apr-May.
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    Learn more about this trial

    A Clinical Evaluation of the Safety and Efficacy of Randomized Placebo Versus the 8-aminoquinoline Tafenoquine for Early Symptom Resolution in Patients With Mild to Moderate COVID 19 Disease and Low Risk of Disease Progression

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