Hydroxychloroquine for Treatment of Non-Severe COVID-19

Covid19 Clinical Trial

— HONEST  

Official title:

The Efficacy and Safety of Hydroxychloroquine for the Treatment Of Non-Severe COVID-19 in Adults in Uganda: A Randomized Open Label Phase II Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04860284
• Other study ID #: MAKRIF/DVCFA/016/20
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 18, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2021
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.These include the antimalarial drugs- chloroquine(CQ) and hydroxychloroquine(HCQ), antivirals such as remdesivir and favipiravir and antiretroviral combination therapies such as lopinavir/ritonavir. Although hydroxychloroquine and chloroquine are readily accessible in Uganda and could be explore for treatment of COVID-19,current data regarding their efficacy and safety is scanty.

It is necessary to determine whether HCQ can be useful for treatment of Ugandan patients with COVID-19 for the following reasons : Firstly, the Ugandan population expresses a high level of variability with a younger population with more than 50% under the age of 15 years. Secondly, the population with co-morbid conditions like diabetes mellitus ,hypertension and cardiovascular disease is significantly lower compared to higher income countries. Preliminary data from the first 52 COVID-19 patients in Uganda treated with HCQ demonstrated faster symptom resolution although this did not reach statistical significance. Lastly, HCQ has not been tested in mild-moderate disease where hospitalization is not necessary and we therefore do not know whether it can lead to faster viral clearance, slow disease progression and reduce time to symptom clearance. Our main aim will be to determine if hydroxychloroquine can lead to faster viral clearance.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: December 1, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Hydroxychloroquine tablets
Hydroxychloroquine tablets 400mg given orally 12 hourly on day 1 and 200mg 12 hourly on day 2 to 5

Locations

Country	Name	City	State
Uganda	Namboole COVID-19 treatment unit	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS COV-2 viral clearance	Attaining a negative PCR- test result i.e. 100% viral clearance	From randomization to day 6
Secondary	Clinical and laboratory adverse events	Grade 3 or 4 adverse events	From randomization to day 6
Secondary	Time to symptom clearance	Time from randomization to symptom clearance	Randomization to day 10
Secondary	Pharmacokinetic-pharmacodynamic model demonstrating drug concentration	Exposure-outcome relationship of hydroxychloroquine	Randomization to day 8
Secondary	Sero-reversion to negative antibody test	Antibody sero-reversion	From randomization to day 90