Hydroxychloroquine for Treatment of Non-Severe COVID-19

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently there are no proven treatments for COVID-19 and current standard therapy is supportive care with oxygen supplementation and treatment of symptoms. Several re-purposed and new drugs have been investigated but none is conclusive for efficacy against COVID-19 .Both Hydroxychloroquine(HCQ) and Chloroquine(CQ) have demonstrated activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and have been investigated in small clinical trials with contradicting reports on their benefits or harm in treatment of COVID-19 .Several authors agree that the use of HCQ for treatment of COVID-19 needs to be assessed in large randomized controlled trials

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

• Patients with a confirmed positive Polymerase chain reaction(PCR) test for SARS COV-2

• Adults of ≥ 18 years

• Evidence of a personally signed and dated informed consent document indicating that the participant(or their legal representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

• Patients with contraindication to the use of hydroxychloroquine e.g. known allergy to hydroxychloroquine

• Patients enrolled in another interventional study which may interfere with study results

• Patients on medication that are known to have clinically significant interactions with the study drug e.g. digoxin, piperaquine, lumefantrine.

• Patients presenting with severe/critically ill COVID-19 (World Health Organization Ordinal scale for clinical improvement score of 5 or more)

• Patients with a fever( temperature ≥ 37.5 degrees centigrade) and a positive rapid diagnostic test (RDT) result for malaria

• Patients with corrected QT interval (QTc) prolongation of > 450ms for males and >470ms for females

• Pregnant or breastfeeding women

• Patients on chronic hydroxychloroquine use