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Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19

Primary Purpose

COVID-19, SARS-CoV 2

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine (HCQ)
Azithromycin (Azithro)
Placebo for Hydroxychloroquine
Placebo for Azithromycin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria:

  • Documentation of confirmed active severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection from any respiratory specimen collected ≤7 days from when the first dose of study treatment was expected to be taken.

  • Experienced at least one of the following SARS-CoV-2 infection symptoms within 24 hours of screening (symptom(s) must be new or worse compared to pre-COVID-19 health status):

    • Fever (can be subjective) or feeling feverish
    • Cough
    • Shortness of breath or difficulty breathing at rest or with exertion
    • Sore throat
    • Body pain or muscle pain
    • Fatigue
    • Headache
  • Agreed to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period up until reaching hospitalization or 20 days, whichever is earliest.
  • Agreed to not obtain study medications outside of the A5395 study.

Exclusion Criteria:

  • Need for hospitalization or immediate medical attention in the clinical opinion of the study investigator.
  • History of or current hospitalization for COVID-19.
  • History of ventricular arrhythmia or use of antiarrhythmics within 30 days prior to entry.
  • Personal or family history of Long QT syndrome.
  • History of kidney disease.
  • History of ischemic or structural heart disease.
  • History of hypokalemia or hypomagnesemia or taking potassium supplementation or magnesium supplementation
  • Personal medical history of porphyria, retinopathy, severe hepatic impairment, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Used drugs with possible anti-SARS-CoV-2 activity within 30 days prior to study entry, e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, and azithromycin, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis.
  • Requirement or expected requirement for a medication that significantly prolongs QT intervals or increases risk for QT prolongation.
  • Loop diuretics are exceptions to above exclusion criterion but these cannot be used within 30 days prior to study entry.
  • Participated in a study where co-enrollment was not allowed.
  • Receipt of a SARS-CoV-2 vaccination prior to study entry.
  • Known allergy/sensitivity or any hypersensitivity to components of HCQ, azithromycin, or their formulation.

  • More than 10 days of any of the following symptoms attributed to the SARS-CoV-2 infection at study entry:

    • Fever (can be subjective) or feeling feverish
    • Cough
    • Shortness of breath or difficulty breathing at rest or with exertion
    • Sore throat
    • Body pain or muscle pain
    • Fatigue
    • Headache
    • Chills
    • Nasal obstruction or congestion
    • Loss of taste or smell
    • Nausea or vomiting
    • Diarrhea

Sites / Locations

  • Alabama CRS
  • UCSD Antiviral Research Center CRS
  • Harbor-UCLA CRS
  • Whitman-Walker Health CRS
  • Northwestern University CRS
  • Rush University CRS
  • Greensboro CRS
  • Cincinnati Clinical Research Site
  • University of Pittsburgh CRS
  • Trinity Health and Wellness Center CRS
  • University of Washington AIDS CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)

Arm B: Placebo for Hydroxychloroquine and Azithromycin

Arm Description

Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).

Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).

Outcomes

Primary Outcome Measures

Number of Participants Who Died From Any Cause or Were Hospitalized
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Formal statistical testing was not conducted due to the small number of participants and events.

Secondary Outcome Measures

Number of Participants Who Died From Any Cause
Deaths reported due to any cause (COVID-related or not)
Number of Participants Who Died From Any Cause, or Were Hospitalized, or Had an Urgent Visit to Emergency Room or Clinic
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization, but was included for this outcome measure.
Number of Participants Who Died From Any Cause or Were Hospitalized Through the End of Follow-up
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Due to the early termination of the study, participant followup was discontinued at Day 20. Refer to the primary outcome above for results based on the time frame out to Day 20.
Number of Participants Who Prematurely Discontinue Study Treatment Due to an Adverse Event
Premature discontinuation of study treatment is defined as a permanent discontinuation of either study treatment (HCQ/Placebo and/or Azithro/Placebo)
Number of Participants Who Had Any Cardiac Adverse Events
Cardiac adverse events included in the analysis were chosen a priori by the study chairs
Duration of Fever
Defined as the time from study treatment initiation to the last day in the participant's daily diary card on which a temperature greater than 100.4°F was recorded or a potentially antipyretic drug, such as acetaminophen or ibuprofen, was taken. Participants with at least one temperature who never reported fever or use of anti-pyretic medications were assigned a duration of zero days
Duration of Symptoms Associated With COVID-19 Disease
Defined as the time from start of study treatment to the last day in the participant's daily diary card on which a moderate or worse targeted symptom was recorded. The set of target symptoms were cough, shortness of breath, feeling feverish, fatigue, muscle aches, diarrhea, vomiting, nausea, headache, sore throat, nasal obstruction (stuffy nose), nasal discharge (runny nose), loss of smell, and loss of taste. Participants who had missing diary records due to hospitalization were assumed to have moderate symptoms during the period of hospitalization in the analysis. Missing diary card records not due to hospitalization were assumed to have absent symptoms.
Participant-specific Area Under the Curve (AUC) of the Symptom Score Associated With COVID-19 Disease Over Time
Defined as the sum of scores for the targeted symptoms (defined in the protocol) in the participant's daily diary record (each symptom was scored from 0-best to 3-worst). Participant-specific areas under the curve (AUC) over time were calculated using the trapezoidal rule and defined as the area below the line formed by joining total symptom scores on each daily diary card from the pre-treatment score on Day 0 through to Day 20. AUCs were rescaled by time by dividing by 21 (corresponding to the number of daily diary cards during follow-up between pre-treatment Day 0 and Day 20), in order to provide results on a symptom scale from 0-best to 42-worst (for non-hospitalized participants). Participants who were hospitalized were assigned a value equal to the sum of the maximum possible scaled AUC (42) and the duration of hospitalization, and thus values >42 were possible. Missing scores between pre-treatment and Day 20 were linearly interpolated. Higher AUCs indicate worse outcomes.
Time to Self-reported Return to Usual (Pre-COVID) Health.
Time to self-reported return to (pre-COVID) usual health was defined as the time from the start of study treatment to the first day in the participant's daily diary card on which they responded 'Yes' with no subsequent reports of 'No' to the question "Have you returned to your usual (pre-COVID) health today?" Participants who never reported a 'Yes' response were assigned a duration of 22 days.
SARS-CoV-2 RNA Detection Status From Self-collected Nasal and Site-collected NP Swabs Among Subset
The virology substudy did not open to enrollment and thus no data on virologic outcomes are available to report
SARS-CoV-2 RNA Level (Continuous) From Self-collected Nasal and Site-collected NP Swabs Among Subset
The virology substudy did not open to enrollment and thus no data on virologic outcomes are available to report
Number of Participants With an Occurrence of Fainting
Fainting was self-reported on the study diary card as absent (score 0), mild (1), moderate (2), or severe (3); scores of > 0 are defined as an occurrence of fainting

Full Information

First Posted
April 20, 2020
Last Updated
November 12, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Teva Pharmaceutical Industries, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04358068
Brief Title
Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
Official Title
A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment and lack of community enthusiasm
Study Start Date
May 13, 2020 (Actual)
Primary Completion Date
July 8, 2020 (Actual)
Study Completion Date
July 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Teva Pharmaceutical Industries, 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
The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.
Detailed Description
This Phase IIB study was designed to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection. Participants were randomized 1:1 to receive active or placebo study treatment. The target sample size was 2000 participants, with approximately 1000 in each arm. Stratification was by "high" versus "low" risk of progression to severe COVID-19, where "high risk" was defined as a person age ≥60 years or having at least one of several specified comorbidities. Participants were prescribed study treatment for 7 days and were to be followed for an additional 24 weeks. Assessments on a subset of participants were planned to include blood collection, self-collected nasal swabs, and nasopharyngeal swabs. On June 23, 2020, sites were informed that the study was closing to follow-up due to slow enrollment and lack of community enthusiasm. Follow-up through week 24 was not completed for any participant. Participants were asked to complete the Day 20 visit and then were discontinued from the study. Due to the early termination, enrollment into the specimen collection subset did not occur, and results associated with those specimens are not available. Due to the small number of participants enrolled, some statistical tests were not able to be performed and only descriptive results are provided.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Hydroxychloroquine (HCQ) and Azithromycin (Azithro)
Arm Type
Experimental
Arm Description
Hydroxychloroquine 400 mg (administered as two 200 mg capsules) orally twice daily for 2 doses starting on Day 0, followed by 200 mg (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Azithromycin 500 mg (administered as two 250 mg capsules) orally as a single dose on Day 0, followed by 250 mg (administered as one 250 mg capsule) orally once daily for 4 doses (4 days).
Arm Title
Arm B: Placebo for Hydroxychloroquine and Azithromycin
Arm Type
Placebo Comparator
Arm Description
Placebo for Hydroxychloroquine (administered as two matching placebo capsules) orally twice daily for 2 doses starting on Day 0, followed by Placebo for HCQ (administered as one 200 mg capsule) orally twice daily for 12 doses (6 days), PLUS: Placebo for Azithromycin (administered as two matching placebo capsules) orally as a single dose on Day 0, followed by Placebo for Azithromycin (administered as one matching placebo capsule) orally once daily for 4 doses (4 days).
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine (HCQ)
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Azithromycin (Azithro)
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo for Hydroxychloroquine
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo for Azithromycin
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Number of Participants Who Died From Any Cause or Were Hospitalized
Description
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Formal statistical testing was not conducted due to the small number of participants and events.
Time Frame
The 20-day period from and including the day of the first dose of study treatment
Secondary Outcome Measure Information:
Title
Number of Participants Who Died From Any Cause
Description
Deaths reported due to any cause (COVID-related or not)
Time Frame
The 20-day period from and including the day of the first dose of study treatment
Title
Number of Participants Who Died From Any Cause, or Were Hospitalized, or Had an Urgent Visit to Emergency Room or Clinic
Description
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization, but was included for this outcome measure.
Time Frame
The 20-day period from and including the day of the first dose of study treatment
Title
Number of Participants Who Died From Any Cause or Were Hospitalized Through the End of Follow-up
Description
Hospitalization was defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care was not considered a hospitalization. Due to the early termination of the study, participant followup was discontinued at Day 20. Refer to the primary outcome above for results based on the time frame out to Day 20.
Time Frame
From day of the first dose of study treatment to Week 24
Title
Number of Participants Who Prematurely Discontinue Study Treatment Due to an Adverse Event
Description
Premature discontinuation of study treatment is defined as a permanent discontinuation of either study treatment (HCQ/Placebo and/or Azithro/Placebo)
Time Frame
From start of study treatment through Day 7
Title
Number of Participants Who Had Any Cardiac Adverse Events
Description
Cardiac adverse events included in the analysis were chosen a priori by the study chairs
Time Frame
From start of study treatment through Day 20
Title
Duration of Fever
Description
Defined as the time from study treatment initiation to the last day in the participant's daily diary card on which a temperature greater than 100.4°F was recorded or a potentially antipyretic drug, such as acetaminophen or ibuprofen, was taken. Participants with at least one temperature who never reported fever or use of anti-pyretic medications were assigned a duration of zero days
Time Frame
Day 0 to Day 20, 21 days total
Title
Duration of Symptoms Associated With COVID-19 Disease
Description
Defined as the time from start of study treatment to the last day in the participant's daily diary card on which a moderate or worse targeted symptom was recorded. The set of target symptoms were cough, shortness of breath, feeling feverish, fatigue, muscle aches, diarrhea, vomiting, nausea, headache, sore throat, nasal obstruction (stuffy nose), nasal discharge (runny nose), loss of smell, and loss of taste. Participants who had missing diary records due to hospitalization were assumed to have moderate symptoms during the period of hospitalization in the analysis. Missing diary card records not due to hospitalization were assumed to have absent symptoms.
Time Frame
Day 0 to Day 20, 21 days total
Title
Participant-specific Area Under the Curve (AUC) of the Symptom Score Associated With COVID-19 Disease Over Time
Description
Defined as the sum of scores for the targeted symptoms (defined in the protocol) in the participant's daily diary record (each symptom was scored from 0-best to 3-worst). Participant-specific areas under the curve (AUC) over time were calculated using the trapezoidal rule and defined as the area below the line formed by joining total symptom scores on each daily diary card from the pre-treatment score on Day 0 through to Day 20. AUCs were rescaled by time by dividing by 21 (corresponding to the number of daily diary cards during follow-up between pre-treatment Day 0 and Day 20), in order to provide results on a symptom scale from 0-best to 42-worst (for non-hospitalized participants). Participants who were hospitalized were assigned a value equal to the sum of the maximum possible scaled AUC (42) and the duration of hospitalization, and thus values >42 were possible. Missing scores between pre-treatment and Day 20 were linearly interpolated. Higher AUCs indicate worse outcomes.
Time Frame
Day 0 to Day 20, 21 days total
Title
Time to Self-reported Return to Usual (Pre-COVID) Health.
Description
Time to self-reported return to (pre-COVID) usual health was defined as the time from the start of study treatment to the first day in the participant's daily diary card on which they responded 'Yes' with no subsequent reports of 'No' to the question "Have you returned to your usual (pre-COVID) health today?" Participants who never reported a 'Yes' response were assigned a duration of 22 days.
Time Frame
Day 0 to Day 20, 21 days total
Title
SARS-CoV-2 RNA Detection Status From Self-collected Nasal and Site-collected NP Swabs Among Subset
Description
The virology substudy did not open to enrollment and thus no data on virologic outcomes are available to report
Time Frame
Measured at entry, Day 6, and Day 20
Title
SARS-CoV-2 RNA Level (Continuous) From Self-collected Nasal and Site-collected NP Swabs Among Subset
Description
The virology substudy did not open to enrollment and thus no data on virologic outcomes are available to report
Time Frame
Measured at entry, Day 6, and Day 20
Title
Number of Participants With an Occurrence of Fainting
Description
Fainting was self-reported on the study diary card as absent (score 0), mild (1), moderate (2), or severe (3); scores of > 0 are defined as an occurrence of fainting
Time Frame
From start of study treatment through Day 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documentation of confirmed active severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection from any respiratory specimen collected ≤7 days from when the first dose of study treatment was expected to be taken. Experienced at least one of the following SARS-CoV-2 infection symptoms within 24 hours of screening (symptom(s) must be new or worse compared to pre-COVID-19 health status): Fever (can be subjective) or feeling feverish Cough Shortness of breath or difficulty breathing at rest or with exertion Sore throat Body pain or muscle pain Fatigue Headache Agreed to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period up until reaching hospitalization or 20 days, whichever is earliest. Agreed to not obtain study medications outside of the A5395 study. Exclusion Criteria: Need for hospitalization or immediate medical attention in the clinical opinion of the study investigator. History of or current hospitalization for COVID-19. History of ventricular arrhythmia or use of antiarrhythmics within 30 days prior to entry. Personal or family history of Long QT syndrome. History of kidney disease. History of ischemic or structural heart disease. History of hypokalemia or hypomagnesemia or taking potassium supplementation or magnesium supplementation Personal medical history of porphyria, retinopathy, severe hepatic impairment, or glucose-6-phosphate dehydrogenase (G6PD) deficiency. Used drugs with possible anti-SARS-CoV-2 activity within 30 days prior to study entry, e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, and azithromycin, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis. Requirement or expected requirement for a medication that significantly prolongs QT intervals or increases risk for QT prolongation. Loop diuretics are exceptions to above exclusion criterion but these cannot be used within 30 days prior to study entry. Participated in a study where co-enrollment was not allowed. Receipt of a SARS-CoV-2 vaccination prior to study entry. Known allergy/sensitivity or any hypersensitivity to components of HCQ, azithromycin, or their formulation. More than 10 days of any of the following symptoms attributed to the SARS-CoV-2 infection at study entry: Fever (can be subjective) or feeling feverish Cough Shortness of breath or difficulty breathing at rest or with exertion Sore throat Body pain or muscle pain Fatigue Headache Chills Nasal obstruction or congestion Loss of taste or smell Nausea or vomiting Diarrhea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davey Smith, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCSD Antiviral Research Center CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Harbor-UCLA CRS
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Whitman-Walker Health CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Greensboro CRS
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Cincinnati Clinical Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Pittsburgh CRS
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Trinity Health and Wellness Center CRS
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-9929
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie results in the publication, after deidentification.
IPD Sharing Time Frame
Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
IPD Sharing Access Criteria
With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group. For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group. By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.
Links:
URL
https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables
Description
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
URL
https://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids
Description
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010

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Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19

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