Hydroxychloroquine in Outpatient Adults With COVID-19

Coronavirus Infection Clinical Trial

Official title:

A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04333654
• Other study ID #: EFC16855
• Secondary ID: 2020-001269-35U1
• Status: Terminated
• Phase: Phase 1
• Start date: April 12, 2020
• Est. completion date: May 26, 2020

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 26, 2020
• Est. primary completion date: May 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections

Intervention

Drug:
• Hydroxychloroquine SAR321068
Pharmaceutical form:Tablet Route of administration: Oral
• Placebo
Pharmaceutical form:Tablet Route of administration: Oral

Locations

Country	Name	City	State
Belgium	Investigational Site Number 0561001	Bruxelles
Belgium	Investigational Site Number 0561002	Lodelinsart
France	Investigational Site Number 2501001	Bordeaux Cedex
France	Investigational Site Number 2501002	Paris
Netherlands	Investigational Site Number 5281001	Groningen
Netherlands	Investigational Site Number 5281002	Harderwijk
United States	Investigational Site Number 8400001	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Day 3 in nasopharyngeal SARS-CoV-2 viral load (if quantitative PCR is available)	Viral load assessed by PCR from a nasopharyngeal swab	Baseline to Day 3
Primary	Number of participants by PCR result status (positive or negative) (if quantitative PCR is not available)	Viral load assessed by PCR from a nasopharyngeal swab - 2. Viral load assessed by PCR from a nasopharyngeal swab	Baseline to Day 3
Secondary	Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load	Viral load assessed by PCR from a nasopharyngeal swab	Baseline to Day 5
Secondary	Number of participants by PCR result status (positive or negative)	Viral load assessed by PCR from a nasopharyngeal swab	Baseline to end of study (Day14)
Secondary	Number of participants with COVID-19 symptoms by severity	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)	Baseline to end of study (Day14)
Secondary	Time to resolution of COVID-19 Symptoms	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	Baseline to end of study (Day14)
Secondary	Time to resolution of fever	Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C	Baseline to end of study (Day14)
Secondary	Percentage of participants with resolution of fever	Resolution of fever defined as the first day of 2 consecutive daily temperatures < 37.7 C	Baseline to end of study (Day14)
Secondary	Percentage of participants hospitalized		Baseline to end of study (Day14)
Secondary	Number of participants with Adverse Events		Baseline to end of study (Day14)