Clinical trial for the treatment of COVID-19 with Chloroquine and Colchicine

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-8jyhxh
• Date of registration: 30/07/2020
• Prospective Registration: No
• Primary sponsor: Hospital das Clínicas de Ribeirão Preto
• Public title: Clinical trial for the treatment of COVID-19 with Chloroquine and Colchicine
• Scientific title: Randomized clinical trial for the treatment of moderate to severe cases of COVID-19 with Chloroquine and Colchicine
• Date of first enrolment: 11/04/2020
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-8jyhxh
• Study type: Intervention
• Study design: Clinical trial of treatment, randomized-controlled, parallel, double-blind, with two arms.
• Phase: 2-3

Countries of recruitment

Brazil

Contacts

• Name: Renê D. Ribeiro Oliveira
• Affiliation: Hospital das Clínicas de Ribeirão Preto

• Name: Renê D. Ribeiro Oliveira
• Affiliation: Hospital das Clínicas de Ribeirão Preto

Key inclusion & exclusion criteria

Inclusion criteria: Moderate or severe forms of COVID-19; 18 years or older; body weight of 50 kg or more; serum Ca2+ and K+ normal; QT interval lower than 450 ms at 12 derivations electrocardiogram; beta-HCG (serum or urine) negative (if woman under 50).
Exclusion criteria: Mild and critical forms of COVID-19; allergy to any of the medications under study; diagnosis of porphyria, myasthenia gravis or uncontrolled arrhythmia at admission; pregnancy; use of digoxin, amiodarone, verapamil or metoprolol; use of protease inhibitors; history of chronic liver disease with liver dysfunction; unable to understand the information contained in the Consent Form.

Age minimum: 18Y
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

B34.2

Coronavirus disease 2019 (COVID-19)

Intervention(s)

E02.319

Randomized clinical trial for treatment of COVID-19 with chloroquine and placebo versus chloroquine and colchicine.

Intervention chloroquine - hydroxychloroquine sulfate 400 mg bid for 1 or 2 (if body weight greater than 80 kg) days, followed by 400 mg daily until 10 days of treatment.

Intervention colchicine - colchicine 0,5 mg tid for 5 days, followed by 0,5 mg bid for 5 days. If body weight greater than 80 kg, a loading dose of 1 mg will be used.

Chloroquine and placebo experimental group: 30 subjects with moderate or severe forms of COVID-19 will receive the intervention chloroquine and placebo according to the scheme: 1 tablet every 8 hours for 5 days, followed by 1 tablet every 12 hours for 5 days.

Experimental group chloroquine and colchicine: 30 subjects with moderate or severe forms of COVID-19 will receive the interventions chloroquine and colchicine.

Primary Outcome(s)

To evaluate the duration of oxygen therapy for both groups, measured in number of days of need of supplemental oxygen by catheter or masks.

To evaluate the percentage of individuals who will require admission to the Intensive Care Unit, due to clinical deterioration. In this situation, due to institutional restriction, the study drugs will be discontinued.

To evaluate the hospitalization time for both groups, measured in number of days from the admission to the discharge.

To evaluate the percentage of death.

Secondary Outcome(s)

Assess the percentage of individuals who will experience adverse events of any kind.

Assess the percentage of treatment interruption due to adverse event.

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo

CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico

Secondary Sponsor(s)

Faculdade de Ciências Farmacêuticas de Ribeirão Preto

Results

• Results available: Yes
• Date Posted: 25/06/2021
• Date Completed: 10/12/2020
• URL: https://rmdopen.bmj.com/content/7/1/e001455