NCT04321278

Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II)

Completed Phase 3 Last updated 20 January 2021

What this trial tests

Phase 3 trial testing Hydroxychloroquine + azithromycin in Coronavirus Infections in 440 participants. Completed in 14 June 2020.

Timeline

28 March 2020

Primary endpoint
14 June 2020

14 June 2020

Quick facts

Lead sponsor	Hospital Israelita Albert Einstein
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	440
Start date	28 March 2020
Primary completion	14 June 2020
Estimated completion	14 June 2020
Sites	58 locations across Brazil

Drugs / interventions tested

• Hydroxychloroquine + azithromycin — full drug profile →
• Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →

Conditions studied

• Coronavirus Infections — all drugs for Coronavirus Infections →
• Pneumonia, Viral — all drugs for Pneumonia, Viral →

Sponsor

Hospital Israelita Albert Einstein

Who can join

18 and older, any sex, with Coronavirus Infections or Pneumonia, Viral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.

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. Can we use interleukin-6 (IL-6) blockade for coronavirus disease 2019 (COVID-19)-induced cytokine release syndrome (CRS)?
   Liu B, Li M, Zhou Z, Guan X, et al · · 2020 · cited 507× · PMID 32291137 · DOI 10.1016/j.jaut.2020.102452
3. Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial.
   Furtado RHM, Berwanger O, Fonseca HA, Corrêa TD, et al · · 2020 · cited 248× · PMID 32896292 · DOI 10.1016/s0140-6736(20)31862-6
4. COVID-19 for the Cardiologist: Basic Virology, Epidemiology, Cardiac Manifestations, and Potential Therapeutic Strategies.
   Atri D, Siddiqi HK, Lang JP, Nauffal V, et al · · 2020 · cited 221× · PMID 32292848 · DOI 10.1016/j.jacbts.2020.04.002
5. COVID-19 and Cancer: a Comprehensive Review.
   Gosain R, Abdou Y, Singh A, Rana N, et al · · 2020 · cited 187× · PMID 32385672 · DOI 10.1007/s11912-020-00934-7
6. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
7. Chloroquine or hydroxychloroquine for prevention and treatment of COVID-19.
   Singh B, Ryan H, Kredo T, Chaplin M, et al · · 2021 · cited 140× · PMID 33624299 · DOI 10.1002/14651858.cd013587.pub2
8. Hydroxychloroquine and COVID-19.
   Sinha N, Balayla G. · · 2020 · cited 107× · PMID 32295814 · DOI 10.1136/postgradmedj-2020-137785