NCT04303507: COPCOV

Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare Setting

Completed NA Last updated 4 April 2023

What this trial tests

NA trial testing Chloroquine or Hydroxychloroquine in COVID19 in 4,652 participants. Completed in 22 March 2022.

Timeline

29 April 2020

Primary endpoint
22 March 2022

22 March 2022

Quick facts

Lead sponsor	University of Oxford
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	4,652
Start date	29 April 2020
Primary completion	22 March 2022
Estimated completion	22 March 2022
Sites	25 locations across Pakistan, Mali, United Kingdom, Indonesia, Zambia, Benin, Thailand, Kenya

Drugs / interventions tested

• Chloroquine or Hydroxychloroquine — full drug profile →
• Placebo

Conditions studied

• COVID19 — all drugs for COVID19 →
• Coronavirus — all drugs for Coronavirus →
• Acute Respiratory Illnesses — all drugs for Acute Respiratory Illnesses →

Sponsor

University of Oxford

Who can join

16 and older, any sex, with COVID19 or Coronavirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a double-blind, randomised, placebo-controlled trial that will be conducted primarily in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other persons at risk of contracting COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000 participants and we predict an average of 400-800 participants per site in 50-100 sites.

The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months.

If the participant is diagnosed with COVID-19, they will take continue to take the study medication until:

* 90 days after enrolment (i.e., completion of kit)
* hospitalised due to COVID-19 disease (i.e., not for quarantine purposes) in which case they will stop, or
* advised to stop by their healthcare professional for other reasons

Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.

This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic.
   Driggin E, Madhavan MV, Bikdeli B, Chuich T, et al · · 2020 · cited 1272× · PMID 32201335 · DOI 10.1016/j.jacc.2020.03.031
2. The epidemiology, diagnosis and treatment of COVID-19.
   Zhai P, Ding Y, Wu X, Long J, et al · · 2020 · cited 461× · PMID 32234468 · DOI 10.1016/j.ijantimicag.2020.105955
3. COVID-19: Transmission, prevention, and potential therapeutic opportunities.
   Lotfi M, Hamblin MR, Rezaei N. · · 2020 · cited 447× · PMID 32474009 · DOI 10.1016/j.cca.2020.05.044
4. COVID-19, immune system response, hyperinflammation and repurposing antirheumatic drugs
   Tufan A, Avanoğlu Güler A, Matucci-Cerinic M. · · 2020 · cited 270× · PMID 32299202 · DOI 10.3906/sag-2004-168
5. Chloroquine and hydroxychloroquine in the treatment of COVID-19 with or without diabetes: A systematic search and a narrative review with a special reference to India and other developing countries.
   Singh AK, Singh A, Shaikh A, Singh R, et al · · 2020 · cited 250× · PMID 32247211 · DOI 10.1016/j.dsx.2020.03.011
6. Ongoing Clinical Trials for the Management of the COVID-19 Pandemic.
   Lythgoe MP, Middleton P. · · 2020 · cited 247× · PMID 32291112 · DOI 10.1016/j.tips.2020.03.006
7. Clinical trials on drug repositioning for COVID-19 treatment.
   Rosa SGV, Santos WC. · · 2020 · cited 225× · PMID 32256547 · DOI 10.26633/rpsp.2020.40
8. Inflamm-aging: Why older men are the most susceptible to SARS-CoV-2 complicated outcomes.
   Bonafè M, Prattichizzo F, Giuliani A, Storci G, et al · · 2020 · cited 145× · PMID 32389499 · DOI 10.1016/j.cytogfr.2020.04.005