Hydroxychloroquine for Treatment of Non-Severe COVID-19

NCT04860284 | Unknown Phase 2 DMC

• 1 other identifier: MAKRIF/DVCFA/016/20
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• SARS COV-2 viral clearance

  Attaining a negative PCR- test result i.e. 100% viral clearance

  From randomization to day 6

Secondary Outcomes (4)

• Clinical and laboratory adverse events

  From randomization to day 6

• Time to symptom clearance

  Randomization to day 10

• Pharmacokinetic-pharmacodynamic model demonstrating drug concentration

  Randomization to day 8

• Sero-reversion to negative antibody test

  From randomization to day 90

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Participants will receive 400mg of hydroxychloroquine tablets 12-hourly on day 1 and 200mg 12-hourly on day 2 to day 5 in addition to standard of care treatment for COVID-19

Drug: Hydroxychloroquine tablets

Control arm

NO INTERVENTION

Participants will receive only standard of care treatment for COVID-19

Interventions

Hydroxychloroquine tablets DRUG

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

Also known as: HCQ

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Namboole COVID-19 treatment unit

Kampala, Uganda

Location

Related Publications (1)

• Byakika-Kibwika P, Sekaggya-Wiltshire C, Semakula JR, Nakibuuka J, Musaazi J, Kayima J, Sendagire C, Meya D, Kirenga B, Nanzigu S, Kwizera A, Nakwagala F, Kisuule I, Wayengera M, Mwebesa HG, Kamya MR, Bazeyo W. Safety and efficacy of hydroxychloroquine for treatment of non-severe COVID-19 among adults in Uganda: a randomized open label phase II clinical trial. BMC Infect Dis. 2021 Dec 6;21(1):1218. doi: 10.1186/s12879-021-06897-9.

  PMID: 34872511 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pauline Byakika-Kibwika, PhD

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 26, 2021
• Study Start: September 18, 2020
• Primary Completion: February 9, 2021
• Study Completion: December 1, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

UG (1)