Clincosm LogoSign in Get a demo

Hydroxychloroquine in Outpatient Adults With COVID-19

Sponsor
Sanofi (Industry)
Overall Status
Terminated
CT.gov ID
NCT04333654
Collaborator
(none)
8
Enrollment
7
Locations
2
Arms
1.4
Actual Duration (Months)
1.1
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19

Secondary Objectives:

  • To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19

  • To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19

Condition or Disease Intervention/Treatment Phase
  • Drug: Hydroxychloroquine SAR321068
  • Drug: Placebo
 Phase 1

Detailed Description

The duration of the study per participant will be around 18 days (1 or 2 days of screening followed by a 10-day treatment period and a 4 to 6 days follow-up period)

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19
Actual Study Start Date :
Apr 12, 2020
Actual Primary Completion Date :
May 26, 2020
Actual Study Completion Date :
May 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hydroxychloroquine

Hydroxychloroquine, loading dose on day 1 followed by a daily maintenance dose during 9 days

Drug: Hydroxychloroquine SAR321068
Pharmaceutical form:Tablet Route of administration: Oral
Other Names:
  • Plaquenil

    		•
    Placebo Comparator: Placebo

    Matching placebo

    Drug: Placebo
    Pharmaceutical form:Tablet Route of administration: Oral

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available) [Baseline to Day 3]

      Viral load assessed by PCR from a nasopharyngeal swab

    2. Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available) [Baseline to Day 3]

      Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab

    Secondary Outcome Measures

    1. Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load [Baseline to Day 5]

      Viral load assessed by PCR from a nasopharyngeal swab

    2. Number of participants by PCR result status (positive or negative) [Baseline to end of study (Day14)]

      Viral load assessed by PCR from a nasopharyngeal swab

    3. Number of participants with COVID-19 symptoms by severity [Baseline to end of study (Day14)]

      COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe)

    4. Time to resolution of COVID-19 Symptoms [Baseline to end of study (Day14)]

      COVID-19 symptoms (feverishness, sore throat, cough, shortness of breath, myalgias) will be scored by the participant on a 4-point scale ( 0 =none; 1 = mild; 2 = moderate; 3 = severe). Resolution of a symptom is defined as when a symptom previously scored ≥ 1 on the scale is scored as 0

    5. Time to resolution of fever [Baseline to end of study (Day14)]

      Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C

    6. Percentage of participants with resolution of fever [Baseline to end of study (Day14)]

      Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C

    7. Percentage of participants hospitalized [Baseline to end of study (Day14)]

    8. Number of participants with Adverse Events [Baseline to end of study (Day14)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria :

    • Participants with diagnosis of COVID-19 via an approved or authorized molecular test

    • Presence of symptoms compatible with COVID-19 at the time of screening

    • Time between onset of symptoms and first dose of hydroxychloroquine or placebo is 96 hours or less

    • Female participants must use an acceptable birth control method, as specified by each site and country

    Exclusion criteria:

    • COVID-19 disease requiring the use of supplemental oxygen

    • Electrocardiogram (ECG) tracing with QTc interval > 450 ms for men, > 470 ms for women (Fridericia algorithm recommended)

    • Bradycardia (< 50 beats/min)

    • History of cardiac disease (eg. congestive heart failure, myocardial infarction)

    • History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency

    • Women who are pregnant or breastfeeding

    • Concurrent antimicrobial therapy

    • Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds

    • Hydroxychloroquine use within 2 months before enrollment

    • History of severe skin reactions such as Sevens-Johnson syndrome and toxic epidermal necrolysis

    • History of retinopathy

    • History of arrythmia, concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death

    • History of severe renal disease (treatment with dialysis or phosphate binders) or hepatic impairment

    The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 8400001 Boston Massachusetts United States 02115
    2 Investigational Site Number 0561001 Bruxelles Belgium BE-1200
    3 Investigational Site Number 0561002 Lodelinsart Belgium 6042
    4 Investigational Site Number 2501001 Bordeaux Cedex France 33076
    5 Investigational Site Number 2501002 Paris France 75005
    6 Investigational Site Number 5281001 Groningen Netherlands 9728 NZ
    7 Investigational Site Number 5281002 Harderwijk Netherlands 3844 DG

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT04333654
    Other Study ID Numbers:
    • EFC16855
    • 2020-001269-35
    • U1111-1249-6168
    First Posted:
    Apr 3, 2020
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coronavirus Infections
    Hydroxychloroquine

    Study Results

    No Results Posted as of Apr 25, 2022