Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

Covid19 Clinical Trial

Official title:

Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349592
• Other study ID #: MRC-05-001
• Status: Completed
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: February 2021
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.

Description:

Reducing viral load is potentially key to reducing viral transmission between humans. Observational data suggests HC and AZ may reduce the viral load. In this study we will randomise ambulatory patients with Covid 19 (confirmed by PCR in combination with clinical symptoms) to receive HC/AZ or HC/placebo or placebo for 7 days. On days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ECG recorded and physical examination performed. On days 15-20, participants will be reviewed by telephone using a semi structured questionnaire. On day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for PCR analysis. Participants will be followed for 6 months via their medical records.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: August 30, 2020
• Est. primary completion date: August 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is in HMC facility for low-acuity, Covid-positive patients being quarantined.

• Positive Covid test on qualitative assay used during routine care (i.e. not as part of Q-PROTECT)

• Age at least 18

Exclusion Criteria:

• Treating physician judges patient not appropriate for study participation for any reason

• Age <18

• Breastfeeding or pregnancy (patient-reported pregnancy status is sufficient)

• Hypersensitivity to chloroquine or HC or AZ

• History of or known QT prolongation

• EKG required before study entry and on each visit during the subject's first seven days on pro-tocol, during the time period HC is being taken

• Baseline QTc >480 if QRS width normal; QTc >510 if QRS >120

• Known G6PD deficiency, porphyria, or retinopathy (eye exam prior to study entry)

• Known hepatic or renal disease (or abnormality on liver or renal function testing at study day 1)

• Low magnesium or low potassium (by testing on day 1)

• Current (pre-study) therapy with antimalarial or dapsone

• Current (pre-study) therapy with antiviral agents (e.g. oseltamivir)

• Tisdale36 score exceeding 6 as tallied below (based on ACC recommendations)*

• 1 point each: age>67, female sex, or being on loop diuretic

• 2 points each: serum potassium <3.6, QTc>449, acute myocardial infarction

• 3 points each: sepsis, heart failure, QT-prolonging drugs

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Hydroxychloroquine
Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
• Azithromycin
Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.

Other:
• Placebo Tablet
Oral, one tablet three times a day for 7 days
• Placebo capsules
Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of virologically cured (PCR-negative status) as assessed on day six	Days	Day 6
Secondary	virologic cure on other study days	Days	Day14 and Day 21
Secondary	virologic semiquantitative analysis of changing viral load	Days	Day 1 to Day 21
Secondary	proportion of initially symtomatic subjects with disappearance of clinical symptoms	Days	Day14 and Day 21
Secondary	proportion of initially asymtomatic subjects with appearance of new clinical symptoms	Days	Day14 and Day 21
Secondary	proportions of subjects with potentially medication- related adverse events	grades	7 day