meta|Evidence - COVID-19
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colchicine (n=50) vs. placebo (n=50)
randomized controlled trial some concerns about risk of bias
Colchicine
1 mg tablet of colchicine daily alongside the Hydroxychloroquine for 6 days.
Placebo
Similar tablet without therapeutic effects alongside the Hydroxychloroquine for 6 days.
HCQ in both groups.
COVID 19 hospitalized
Unclear
Single center, Imam Reza hospital in Ardabil city, Iran.
Blindness unclear: Prospective, open-label, randomized and double blind clinical trial. The participants of the placebo group were received a similar tablet without therapeutic effects.
None of the patients died or were readmitted.
colchicine (n=19) vs. placebo (n=19)
randomized controlled trial high risk of bias
Colchicine
0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The first dose was 1.0 mg whether body weight was ≥ 80 kg.
Placebo
All participants received the institutional treatment for COVID-19 with azithromycin 500 mg once daily for up to 7 days, hydroxychloroquine 400 mg twice daily for 2 days, then 400 mg once daily for up to 8 days and unfractionated heparin 5000 UI thrice daily until the end of hospitalization. Methylprednisolone 0.5 mg/kg/day for 5 days could be added if the need for supplemental oxygen was 6 L/min or more.
COVID 19 hospitalized
Individuals hospitalized with moderate or severe forms of COVID-19 diagnosed by RT-PCR in nasopharyngeal swab specimens and lung computed tomography scan involvement compatible with COVID-19 pneumonia; older than 18 years; body weight > 50 kg; normal levels of serum Ca2 and K ; QT interval < 450 ms at 12 derivations electrocardiogram (according to the Bazett formula) and negative serum or urinary β-HCG if woman under 50. Patients with mild form of COVID-19 or in need for ICU admission were excluded.
Double-blind.
Single-center, Brazil.
Interim analysis. Neither protocol nor statistical plan available.
colchicine (n=55) vs. standard of care (n=50)
randomized controlled trial some concerns about risk of bias
Colchicine
1.5-mg loading dose followed by 0.5 mg after 60 min (in the case of azithromycin coadministration, a single 1.0-mg loading dose of colchicine was administered) and maintenance doses of 0.5 mg twice daily for as long as 3 weeks. Surveillance of gastrointestinal effects after the loading dose.
Standard treatment
Local protocols
Standard of care in both groups.
COVID 19 hospitalized
Patients >18 years old with laboratory confirmed SARS-CoV-2 infection (RT PCR) AND body temperature >37.5 degrees centigrade AND at least two of: i. sustained coughing, ii. sustained throat pain, iii. anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2<95 mmHg, were considered eligible.Patients with clinical assessment indicating that ventilatory support would be inevitable in the following 24 hours because of rapidly declining respiratory status were excluded.
Open-label.
16 tertiary care hospitals in Greece.
Study end point analysis was planned to be performed in 2 phases, an early biochemical phase and a later clinical phase. The 7-grade ordinal scale consisted of the following levels: 1, ambulatory, normal activities; 2, ambulatory but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both; and 7, death.
primary endpoints of low clinical relevence
colchicine (n=5610) vs. standard of care (n=5730)
randomized controlled trial some concerns about risk of bias
Colchicine
Usual care plus colchicine 1 mg after randomisation followed by 500 µg 12 h later and then 500 µg twice a day by mouth or nasogastric tube for 10 days in total or until discharge.
Usual care
94% of patients were being treated with a corticosteroid. As a platform trial, and in a factorial design, patients could be simultaneously randomly assigned to other treatment groups: 1) convalescent plasma versus casirivimab and imdevimab versus usual care, 2) aspirin versus usual care, and 3) baricitinib versus usual care. Until Jan 24, 2021, the trial also allowed a subsequent randomisation for patients with progressive COVID-19 (evidence of hypoxia and a hyperinflammatory state) to receive usual care plus tocilizumab or usual care alone.
COVID 19 hospitalized
Patients admitted to hospital were eligible for the study if they had clinically suspected or laboratory confirmed SARS-CoV-2 infection and no medical history that might, in the opinion of the attending clinician, put the patient at significant risk if they were to participate in the trial. Children and pregnant women were not eligible to receive colchicine.
Open-label.
177 hospitals in the UK, 2 hospitals in Indonesia, 2 hospitals in Nepal.
colchicine (n=640) vs. standard of care (n=639)
randomized controlled trial some concerns about risk of bias
Colchicine
Usual care plus colchicine administered orally in a loading dose of 1.5mg immediately after randomization, followed by 0.5mg orally within 2 hours of the initial dose and 0.5mg orally twice a day for 14 days or discharge, whichever occurred first.
Usual care
local standard of care for COVID-19 SARS moderate /high-risk patients
COVID 19 hospitalized
Consented adults (age ≥18 years)COVID-19 suspicious andadmitted to hospital or already in hospital and fever (with or without at the time of randomization) andSARS (severe acute respiratory syndrome)-shortness of breath (dyspnea) or-image of typical or atypical pneumonia or-oxygen desaturation (spO2 ≤ 93)
Open-label.
42 centers in Argentina.
The original trial protocol included in-hospital mortality as the primary outcome and the composite of a new requirement for mechanical ventilation or death as a key secondaryoutcome. Due to low recruitment rate and low likelihood of reaching the original estimated sample size of 2500 patients, the executive committee decided to change the primary outcome in November 2020 prior to knowing the results to include 2 coprimary hierarchical outcomes with the aim of reducing the trial sample size and potentially getting an earlier result.
colchicine (n=5610) vs. standard of care (n=5730)
randomized controlled trial some concerns about risk of bias
colchicine twice daily for 10 days or until discharge plus usual standard of care
usual standard of care alone
COVID 19 hospitalized
open-label
UK
Colchicine plus rosuvastatin (n=161) vs. standard of care (n=162)
randomized controlled trial some concerns about risk of bias
Colchicine plus rosuvastatin
Standard of care
The standard of care follows the recommendations of the Colombian Consensus forCovid-19 Treatment in Hospitalized Patients,21 consisting of the use of dexamethasone,antiparasitic treatment (ivermectin or albendazole), enoxaparin, acetaminophen, oxygen asneeded, and supportive treatment for organ failure (i.e., use mechanical ventilation, ordialysis).
COVID 19 hospitalized
Adults aged 18 years or more, with a positive real-time polymerase chain reaction (RT-PCR) or with high suspicion of SARS CoV-2 by clinical criteria and a diagnosis of mild, severe, or critical pneumonia, requiring hospital management in six high complexity referral hospitals located in Bogota.
Open-label.
6 hospitals in Bogota, Colombia.
Relative Risks adjusted for age, sex, and severity of pneumonia using g Log-binomial General Estimating Equation models, assuming exchangeable correlation structure with each center as a cluster.
colchicine (n=52) vs. standard of care (n=51)
randomized controlled trial some concerns about risk of bias
Colchicine
Standard of care plus initial dose of 1.5 mg (1 mg and 0.5 mg two hours after) of colchicine, followed by 0.5 mg every 12 hours during the next 7 days and 0.5 mg every 24 hours until the completion of 28 days of total treatment.
Standard of care
Both colchicine and control group patients received the recommended standard treatment in the study: dexamethasone (6 mg once a day for 10 days) in patients who required supplemental oxygen (WHO scale ≥4). Remdesivir was administered for 5 days following the Spanish Agency of Medications and Pharmaceutical Products recommendation which included: time from symptoms onset <7 days; two or more measurements of oxygen saturation below 94% on room air, respiratory rate >24 breaths/min without supplemental oxygen or Pa02/Fi02<300 (Kirby index). Tocilizumab was administered at a single dose of 600 mg and baricitinib at 4 mg/day for 14 days. The need for tocilizumab or baricitinib was established according to the physician on care criteria.
COVID-19 mild to moderate
Exclusion of patient needing mechanical ventilation, non-invasive or invasive, or extracorporeal membrane oxygenation support (ECMO).
Open-label, randomized.
Virgen de la Arrixaca University Clinical Hospital, Murcia, Spain.
multiple testing102 patients
colchicine (n=66) vs. placebo (n=60)
randomized controlled trial risk of bias NA
Colchicine
1.5 mg at baseline then, 0.5 mg PO BID for 10 days.
Placebo
COVID-19 severe or critically
excluded patients : - treated with antimalarial drugs, azithromycin, convalescent plasma, remdesivir, tocilizumab, or baricitinib- subjects over 70 years old,
triple blind
Mexico
After the second pre-specified interim analysis, the committee informed the research group that although the treatment was safe, itwas inefective to prevent the development of the primary outcome and we decided to suspend the trial.
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