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

Conditions

Coronavirus disease 2019 (COVID-19)

Natália B. do Amaral, Tamara Silva Rodrigues, Marcela C Giannini, Maria Isabel Fernandes Lopes, Letícia Pastorelli Bonjorno et al. (34 authors)

Inflammation Research2023-03-1421 citations

10.1007/s00011-023-01718-y

FRAGILE-COLCOVID19: A Clinical Trial Based on Early Administration of an Oral Combination of Colchicine and Prednisone in Elderly Patients with COVID-19 in Geriatric Facilities

José Hernández‐Rodríguez, Julio Durán-Sanclemente, Sergio Prieto‐González, Olga Araújo, Teresa Hospital-Vidal et al. (89 authors)

Clinical Drug Investigation2022-09-293 citations

10.1007/s40261-022-01201-2

Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial

Maria Isabel Fernandes Lopes, Letícia Pastorelli Bonjorno, Marcela C Giannini, Natália B. do Amaral, Pamella Indira Menezes et al. (34 authors)

RMD Open2021-02-01237 citations

10.1136/rmdopen-2020-001455

Interventions

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 bod

E02.319

Eligibility

Age

18 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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 hospitalization time for both groups, measured in number of days from the admission to the discharge.;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 percentage of death.	—

Measure

Time frame

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 hospitalization time for both groups, measured in number of days from the admission to the discharge.;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 percentage of death.

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Secondary

Measure	Time frame
Assess the percentage of individuals who will experience adverse events of any kind.;Assess the percentage of treatment interruption due to adverse event.	—

Countries

Brazil

Contacts

Public ContactRenê Oliveira

Hospital das Clínicas de Ribeirão Preto

rdroliveira@hcrp.usp.br+55-016-36022717

Outcome results

None listed