Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hydroxychloroquine in Outpatient Adults With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333654
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

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
Coronavirus Infection 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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 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 : April 12, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020


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 Name: Plaquenil

Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Pharmaceutical form:Tablet Route of administration: Oral




Primary Outcome Measures :
  1. Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline to Day 5 ]
    Viral load assessed by PCR from a nasopharyngeal swab

  2. Number of participants by PCR result status (positive or negative) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline to end of study (Day14) ]
  8. Number of participants with Adverse Events [ Time Frame: Baseline to end of study (Day14) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Participants with diagnosis of COVID-19 via nasopharyngeal swab Polymerase Chain Reaction (PCR)
  • Time between onset of symptoms and enrollment is 72 hours or less

Exclusion criteria:

  • Severe COVID-19 requiring inpatient treatment
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333654


Contacts
Layout table for location contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
Layout table for location information
United States, Massachusetts
Investigational Site Number 8400001 Recruiting
Boston, Massachusetts, United States, 02115
Belgium
Investigational Site Number 0561001 Recruiting
Bruxelles, Belgium, BE-1200
Investigational Site Number 0561002 Recruiting
Lodelinsart, Belgium, 6042
France
Investigational Site Number 2501001 Recruiting
Bordeaux Cedex, France, 33076
Investigational Site Number 2501002 Recruiting
Paris, France, 75005
Netherlands
Investigational Site Number 5281001 Recruiting
Groningen, Netherlands, 9728 NZ
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04333654    
Other Study ID Numbers: EFC16855
2020-001269-35 ( EudraCT Number )
U1111-1249-6168 ( Other Identifier: UTN )
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydroxychloroquine
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents