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1.
Ann Med ; 54(1): 1956-1965, 2022 12.
Article in English | MEDLINE | ID: covidwho-1931623

ABSTRACT

AIM: This meta-analysis aimed to assess the usefulness of colchicine in patients with COVID-19. METHODS: PubMed, Web of Science, Ovid MEDLINE, the Cochrane Library, Embase, and Clinicaltrials.gov were searched for relevant randomised controlled trials (RCTs) published between database inception and November 12, 2021. Only RCTs that compared the clinical efficacy and safety of colchicine with other alternative treatments or placebos in patients with COVID-19 were included. RESULTS: Overall, 7 RCTs involving 16,024 patients were included; 7,794 patients were in the study group receiving colchicine and 8,230 were in the control group receiving placebo or standard treatment. The study and control groups had similar risk of mortality (odds ratio [OR], 1.00; 95% CI, 0.91-1.09; I2 = 0%). No significant difference was observed between the study and control groups in terms of the need for non-invasive ventilation (OR, 0.92; 95% CI, 0.83-1.03; I2 = 0%), the need for mechanical ventilation (OR, 0.64; 95% CI, 0.32-1.32; I2 = 58%), and length of hospital stay (mean difference, -0.42 days; 95% CI, -1.95 to 1.11; I2 = 62%). In addition, colchicine was associated with significantly higher risks of gastrointestinal adverse events (OR, 1.81; 95% CI, 1.56-2.11; I2 = 0%) and diarrhoea (OR, 2.12; 95% CI, 1.75-2.56; I2 = 9%). CONCLUSIONS: Colchicine does not improve clinical outcomes in patients with COVID-19, so it did not support the additional use of colchicine in the treatment of patients with COVID-19.Key messageColchicine could not reduce the mortality of patients with COVID-19.No significant difference was observed between the colchicine and comparators in terms of the need for non-invasive ventilation, need for mechanical ventilation, and length of hospital stay.Colchicine was associated with a higher risk of gastrointestinal adverse events.


Subject(s)
COVID-19 , COVID-19/drug therapy , Colchicine/adverse effects , Humans , Length of Stay , Randomized Controlled Trials as Topic , Respiration, Artificial , Treatment Outcome
3.
Phytother Res ; 36(2): 891-898, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1694652

ABSTRACT

Colchicine has shown clinical benefits in the management of COVID-19 via its anti-inflammatory effect. However, the exact role of colchicine in COVID-19 patients is unknown. The current clinical trial was performed on 202 patients with moderate to severe COVID-19. Patients were randomly assigned in a 1:1 ratio to receive up to a 3-day course of 0.5 mg colchicine followed by a 12-day course of 1 mg colchicine in combination with standard care or a 15-day course of standard care. Among 202 randomized patients, 153 completed the study and received colchicine/standard care or continued standard care (M age, 54.72 [SD, 15.03] years; 93 [63.1%] men). On day 14, patients in the colchicine/standard care group had significantly higher odds of a better clinical status distribution on chest CT evaluation (p = .048). Based on NYHA classification, the percentage change of dyspnea on day 14 between groups was statistically significant (p = .026), indicating a mean of 31.94% change in the intervention group when compared with 19.95% in the control group. According to this study, colchicine can improve clinical outcomes and reduce pulmonary infiltration in COVID-19 patients if contraindications and precautions are considered and it is prescribed at the right time and in appropriate cases.


Subject(s)
COVID-19 , Colchicine/adverse effects , Humans , Male , Middle Aged , Prospective Studies , SARS-CoV-2 , Treatment Outcome
4.
Cochrane Database Syst Rev ; 10: CD015045, 2021 10 18.
Article in English | MEDLINE | ID: covidwho-1620089

ABSTRACT

BACKGROUND: The development of severe coronavirus disease 2019 (COVID-19) and poor clinical outcomes are associated with hyperinflammation and a complex dysregulation of the immune response. Colchicine is an anti-inflammatory medicine and is thought to improve disease outcomes in COVID-19 through a wide range of anti-inflammatory mechanisms. Patients and healthcare systems need more and better treatment options for COVID-19 and a thorough understanding of the current body of evidence. OBJECTIVES: To assess the effectiveness and safety of Colchicine as a treatment option for COVID-19 in comparison to an active comparator, placebo, or standard care alone in any setting, and to maintain the currency of the evidence, using a living systematic review approach. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register (comprising CENTRAL, MEDLINE (PubMed), Embase, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and medRxiv), Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index), and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions to 21 May 2021. SELECTION CRITERIA: We included randomised controlled trials evaluating colchicine for the treatment of people with COVID-19, irrespective of disease severity, age, sex, or ethnicity. We excluded studies investigating the prophylactic effects of colchicine for people without severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection but at high risk of SARS-CoV-2 exposure. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. We used the Cochrane risk of bias tool (ROB 2) to assess bias in included studies and GRADE to rate the certainty of evidence for the following prioritised outcome categories considering people with moderate or severe COVID-19: all-cause mortality, worsening and improvement of clinical status, quality of life, adverse events, and serious adverse events and for people with asymptomatic infection or mild disease: all-cause mortality, admission to hospital or death, symptom resolution, duration to symptom resolution, quality of life, adverse events, serious adverse events. MAIN RESULTS: We included three RCTs with 11,525 hospitalised participants (8002 male) and one RCT with 4488 (2067 male) non-hospitalised participants. Mean age of people treated in hospital was about 64 years, and was 55 years in the study with non-hospitalised participants. Further, we identified 17 ongoing studies and 11 studies completed or terminated, but without published results. Colchicine plus standard care versus standard care (plus/minus placebo) Treatment of hospitalised people with moderate to severe COVID-19 All-cause mortality: colchicine plus standard care probably results in little to no difference in all-cause mortality up to 28 days compared to standard care alone (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.93 to 1.08; 2 RCTs, 11,445 participants; moderate-certainty evidence). Worsening of clinical status: colchicine plus standard care probably results in little to no difference in worsening of clinical status assessed as new need for invasive mechanical ventilation or death compared to standard care alone (RR 1.02, 95% CI 0.96 to 1.09; 2 RCTs, 10,916 participants; moderate-certainty evidence). Improvement of clinical status: colchicine plus standard care probably results in little to no difference in improvement of clinical status, assessed as number of participants discharged alive up to day 28 without clinical deterioration or death compared to standard care alone (RR 0.99, 95% CI 0.96 to 1.01; 1 RCT, 11,340 participants; moderate-certainty evidence). Quality of life, including fatigue and neurological status: we identified no studies reporting this outcome. Adverse events: the evidence is very uncertain about the effect of colchicine on adverse events compared to placebo (RR 1.00, 95% CI 0.56 to 1.78; 1 RCT, 72 participants; very low-certainty evidence). Serious adverse events: the evidence is very uncertain about the effect of colchicine plus standard care on serious adverse events compared to standard care alone (0 events observed in 1 RCT of 105 participants; very low-certainty evidence). Treatment of non-hospitalised people with asymptomatic SARS-CoV-2 infection or mild COVID-19 All-cause mortality: the evidence is uncertain about the effect of colchicine on all-cause mortality at 28 days (Peto odds ratio (OR) 0.57, 95% CI 0.20 to 1.62; 1 RCT, 4488 participants; low-certainty evidence). Admission to hospital or death within 28 days: colchicine probably slightly reduces the need for hospitalisation or death within 28 days compared to placebo (RR 0.80, 95% CI 0.62 to 1.03; 1 RCT, 4488 participants; moderate-certainty evidence). Symptom resolution: we identified no studies reporting this outcome. Quality of life, including fatigue and neurological status: we identified no studies reporting this outcome. Adverse events: the evidence is uncertain about the effect of colchicine on adverse events compared to placebo . Results are from one RCT reporting treatment-related events only in 4412 participants (low-certainty evidence). Serious adverse events: colchicine probably slightly reduces serious adverse events (RR 0.78, 95% CI 0.61 to 1.00; 1 RCT, 4412 participants; moderate-certainty evidence). Colchicine versus another active treatment (e.g. corticosteroids, anti-viral drugs, monoclonal antibodies) No studies evaluated this comparison. Different formulations, doses, or schedules of colchicine No studies assessed this. AUTHORS' CONCLUSIONS: Based on the current evidence, in people hospitalised with moderate to severe COVID-19 the use of colchicine probably has little to no influence on mortality or clinical progression in comparison to placebo or standard care alone. We do not know whether colchicine increases the risk of (serious) adverse events. We are uncertain about the evidence of the effect of colchicine on all-cause mortality for people with asymptomatic infection or mild disease. However, colchicine probably results in a slight reduction of hospital admissions or deaths within 28 days, and the rate of serious adverse events compared with placebo. None of the studies reported data on quality of life or compared the benefits and harms of colchicine versus other drugs, or different dosages of colchicine. We identified 17 ongoing and 11 completed but not published RCTs, which we expect to incorporate in future versions of this review as their results become available. Editorial note: due to the living approach of this work, we monitor newly published results of RCTs on colchicine on a weekly basis and will update the review when the evidence or our certainty in the evidence changes.


Subject(s)
COVID-19 , Colchicine , Cause of Death , Colchicine/adverse effects , Humans , Male , Middle Aged , Quality of Life , SARS-CoV-2
5.
Int J Infect Dis ; 116: 387-390, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1620729

ABSTRACT

OBJECTIVE: A predictive model for hospitalization due to COVID-19 or death was developed in the placebo group (N=2,084) from a large clinical trial of colchicine in COVID-19 patients (N = 4,159). RESULTS: The 7 variables retained in the predictive model were age, gender, body-mass index, history of respiratory disease, use of diabetes drugs, use of anticoagulants, and use of oral steroids at the time of randomization. An optimal threshold value identified from the predictive model was used to classify high-risk patients (those with a predicted probability above the optimal threshold) and low-risk patients (those with a predicted probability below the optimal threshold). The number needed to treat to prevent 1 hospitalization or death with colchicine treatment decreased from 71 in the whole study population (N = 4,159) to 29 in the high-risk subgroup (N=1,692). CONCLUSION: This model could serve to identify high-risk subjects who will particularly benefit from early colchicine therapy.


Subject(s)
COVID-19 , COVID-19/drug therapy , Colchicine/adverse effects , Colchicine/therapeutic use , Hospitalization , Humans , Risk Factors , SARS-CoV-2 , Treatment Outcome
6.
J Gen Intern Med ; 37(1): 4-14, 2022 01.
Article in English | MEDLINE | ID: covidwho-1611487

ABSTRACT

BACKGROUND: Colchicine is an available, safe, and effective anti-inflammatory drug and has been suggested as a COVID-19 treatment, but its usefulness in hospitalized severe COVID-19 patients has not been thoroughly demonstrated. OBJECTIVE: To address the safety and efficacy of colchicine in hospitalized patients with severe COVID-19. DESIGN: We conducted a triple-blind parallel non-stratified placebo-controlled clinical trial. PARTICIPANTS: We recruited 116 hospitalized patients with severe COVID-19 in Mexico. INTERVENTIONS: Patients were randomized to receive 1.5 mg of colchicine or placebo at the time of the recruitment in the study (baseline) and 0.5 mg BID PO to complete 10 days of treatment. MAIN MEASURES: The primary composite outcome was the progression to critical disease or death. Besides, we evaluated immunological features at baseline and after recovery or disease progression in 20 patients. KEY RESULTS: Fifty-six patients were allocated to colchicine and 60 patients received placebo. The study was suspended after the second interim analysis demonstrated colchicine had no effect on the primary outcome (OR 0.83, 95%CI 0.35-1.93, P = 0.67), nor in the days of ICU and hospital stays. Adverse events were similar between groups (OR 1.63, 95% CI 0.66-3.88, P = 0.37). After colchicine treatment, patients had higher BUN and lower serum levels of IL-8, IL-12p70, and IL-17A. CONCLUSIONS: Colchicine is safe but not effective in the treatment of severe COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04367168.


Subject(s)
COVID-19 , COVID-19/drug therapy , Colchicine/adverse effects , Hospitalization , Humans , SARS-CoV-2 , Treatment Outcome
7.
JAMA Netw Open ; 4(12): e2141328, 2021 12 01.
Article in English | MEDLINE | ID: covidwho-1592856

ABSTRACT

Importance: Hospitalized patients with COVID-19 pneumonia have high rates of morbidity and mortality. Objective: To assess the efficacy of colchicine in hospitalized patients with COVID-19 pneumonia. Design, Setting, and Participants: The Estudios Clínicos Latino América (ECLA) Population Health Research Institute (PHRI) COLCOVID trial was a multicenter, open-label, randomized clinical trial performed from April 17, 2020, to March 28, 2021, in adults with confirmed or suspected SARS-CoV-2 infection followed for up to 28 days. Participants received colchicine vs usual care if they were hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome or oxygen desaturation. The main exclusion criteria were clear indications or contraindications for colchicine, chronic kidney disease, and negative results on a reverse transcription-polymerase chain reaction test for SARS-CoV-2 before randomization. Data were analyzed from June 20 to July 25, 2021. Interventions: Patients were assigned in a 1:1 ratio to usual care or usual care plus colchicine. Colchicine was administered orally in a loading dose of 1.5 mg immediately after randomization, followed by 0.5 mg orally within 2 hours of the initial dose and 0.5 mg orally twice a day for 14 days or discharge, whichever occurred first. Main Outcomes and Measures: The first coprimary outcome was the composite of a new requirement for mechanical ventilation or death evaluated at 28 days. The second coprimary outcome was death at 28 days. Results: A total of 1279 hospitalized patients (mean [SD] age, 61.8 [14.6] years; 449 [35.1%] women and 830 [64.9%] men) were randomized, including 639 patients in the usual care group and 640 patients in the colchicine group. Corticosteroids were used in 1171 patients (91.5%). The coprimary outcome of mechanical ventilation or 28-day death occurred in 160 patients (25.0%) in the colchicine group and 184 patients (28.8%) in the usual care group (hazard ratio [HR], 0.83; 95% CI, 0.67-1.02; P = .08). The second coprimary outcome, 28-day death, occurred in 131 patients (20.5%) in the colchicine group and 142 patients (22.2%) in the usual care group (HR, 0.88; 95% CI, 0.70-1.12). Diarrhea was the most frequent adverse effect of colchicine, reported in 68 patients (11.3%). Conclusions and Relevance: This randomized clinical trial found that compared with usual care, colchicine did not significantly reduce mechanical ventilation or 28-day mortality in patients hospitalized with COVID-19 pneumonia. Trial Registration: ClinicalTrials.gov Identifier: NCT04328480.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , COVID-19/therapy , Colchicine/therapeutic use , Hospitalization , Intubation, Intratracheal , Respiration, Artificial , Adrenal Cortex Hormones/therapeutic use , Adult , Aged , Anti-Inflammatory Agents/adverse effects , COVID-19/mortality , COVID-19/pathology , Colchicine/adverse effects , Female , Humans , Inflammation/drug therapy , Inflammation/etiology , Male , Middle Aged , SARS-CoV-2 , Standard of Care
8.
RMD Open ; 7(3)2021 10.
Article in English | MEDLINE | ID: covidwho-1511509

ABSTRACT

BACKGROUND: Colchicine, an anti-inflammatory drug is prescribed nowadays for COVID-19. In this meta-analysis, we evaluated efficacy and safety of colchicine in patients with COVID-19. METHODS: We searched databases for randomised controlled studies evaluating efficacy and/or safety of colchicine as compared with supportive care in patients with COVID-19. The efficacy outcomes were mortality, ventilatory support, intensive care unit (ICU) admission and length of hospital stay. The safety outcomes were adverse events, serious adverse events and diarrhoea. A meta-analytical summary was estimated using random effects model through Mantle-Hanzle method. An I2 test was used to assess heterogeneity. The Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach was used to assess quality of evidence for each outcome. RESULTS: Out of 69 full texts assessed, 6 studies (16148 patients with COVID-19) were included in meta-analysis. Patients receiving colchicine did not show significant reduction in mortality (risk difference, RD -0.00 (95% CI -0.01 to 0.01), I2=15%), ventilatory support (risk ratio, RR 0.67 (95% CI 0.38 to 1.21), I2=47%), ICU admission (RR 0.49 (95% CI 0.19 to 1.25), I2=34%), length of hospital stay (mean difference: -1.17 (95% CI -3.02 to 0.67), I2=77%) and serious adverse events (RD -0.01 (95% CI -0.02 to 0.00), I2=28%) than those who received supportive care only. Patients receiving colchicine had higher rates of adverse events (RR 1.58 (95% CI 1.07 to 2.33), I2=81%) and diarrhoea (RR 1.93 (95% CI 1.62 to 2.29), I2=0%) than supportive care treated patients. The GRADE quality of evidence was moderate for most outcomes. CONCLUSION: The moderate quality evidence suggests no benefit of addition of colchicine to the standard care regimen in patients with COVID-19.


Subject(s)
COVID-19 , Colchicine/adverse effects , Humans , SARS-CoV-2
9.
Lancet Respir Med ; 9(8): 924-932, 2021 08.
Article in English | MEDLINE | ID: covidwho-1413874

ABSTRACT

BACKGROUND: Evidence suggests a role for excessive inflammation in COVID-19 complications. Colchicine is an oral anti-inflammatory medication beneficial in gout, pericarditis, and coronary disease. We aimed to investigate the effect of colchicine on the composite of COVID-19-related death or hospital admission. METHODS: The present study is a phase 3, randomised, double-blind, adaptive, placebo-controlled, multicentre trial. The study was done in Brazil, Canada, Greece, South Africa, Spain, and the USA, and was led by the Montreal Heart Institute. Patients with COVID-19 diagnosed by PCR testing or clinical criteria who were not being treated in hospital were eligible if they were at least 40 years old and had at least one high-risk characteristic. The randomisation list was computer-generated by an unmasked biostatistician, and masked randomisation was centralised and done electronically through an automated interactive web-response system. The allocation sequence was unstratified and used a 1:1 ratio with a blocking schema and block sizes of six. Patients were randomly assigned to receive orally administered colchicine (0·5 mg twice per day for 3 days and then once per day for 27 days thereafter) or matching placebo. The primary efficacy endpoint was the composite of death or hospital admission for COVID-19. Vital status at the end of the study was available for 97·9% of patients. The analyses were done according to the intention-to-treat principle. The COLCORONA trial is registered with ClinicalTrials.gov (NCT04322682) and is now closed to new participants. FINDINGS: Trial enrolment began in March 23, 2020, and was completed in Dec 22, 2020. A total of 4488 patients (53·9% women; median age 54·0 years, IQR 47·0-61·0) were enrolled and 2235 patients were randomly assigned to colchicine and 2253 to placebo. The primary endpoint occurred in 104 (4·7%) of 2235 patients in the colchicine group and 131 (5·8%) of 2253 patients in the placebo group (odds ratio [OR] 0·79, 95·1% CI 0·61-1·03; p=0·081). Among the 4159 patients with PCR-confirmed COVID-19, the primary endpoint occurred in 96 (4·6%) of 2075 patients in the colchicine group and 126 (6·0%) of 2084 patients in the placebo group (OR 0·75, 0·57-0·99; p=0·042). Serious adverse events were reported in 108 (4·9%) of 2195 patients in the colchicine group and 139 (6·3%) of 2217 patients in the placebo group (p=0·051); pneumonia occurred in 63 (2·9%) of 2195 patients in the colchicine group and 92 (4·1%) of 2217 patients in the placebo group (p=0·021). Diarrhoea was reported in 300 (13·7%) of 2195 patients in the colchicine group and 161 (7·3%) of 2217 patients in the placebo group (p<0·0001). INTERPRETATION: In community-treated patients including those without a mandatory diagnostic test, the effect of colchicine on COVID-19-related clinical events was not statistically significant. Among patients with PCR-confirmed COVID-19, colchicine led to a lower rate of the composite of death or hospital admission than placebo. Given the absence of orally administered therapies to prevent COVID-19 complications in community-treated patients and the benefit of colchicine in patients with PCR-proven COVID-19, this safe and inexpensive anti-inflammatory agent could be considered for use in those at risk of complications. Notwithstanding these considerations, replication in other studies of PCR-positive community-treated patients is recommended. FUNDING: The Government of Quebec, the Bill & Melinda Gates Foundation, the National Heart, Lung, and Blood Institute of the US National Institutes of Health, the Montreal Heart Institute Foundation, the NYU Grossman School of Medicine, the Rudin Family Foundation, and philanthropist Sophie Desmarais.


Subject(s)
COVID-19 , Colchicine , Administration, Oral , Ambulatory Care/methods , Ambulatory Care/statistics & numerical data , Anti-Inflammatory Agents/administration & dosage , Anti-Inflammatory Agents/adverse effects , COVID-19/diagnosis , COVID-19/drug therapy , COVID-19/epidemiology , Colchicine/administration & dosage , Colchicine/adverse effects , Double-Blind Method , Drug Monitoring/methods , Female , Hospitalization/statistics & numerical data , Humans , Intention to Treat Analysis , Male , Middle Aged , Outcome Assessment, Health Care , Risk Assessment , SARS-CoV-2/isolation & purification
10.
Trials ; 22(1): 590, 2021 Sep 06.
Article in English | MEDLINE | ID: covidwho-1398877

ABSTRACT

BACKGROUND: There is no strong evidence that any drug is beneficial either for the treatment of SARS-CoV-2 disease or for post-exposure prophylaxis. Therefore, clinical research is crucial to generate results and evaluate strategies against COVID-19. Primary care (PC) centers, the first level of care in the health system, are in a favorable position to carry out clinical trials (CD), as they work with a large volume of patients with varied profiles (from acute to chronic pathologies). During the COVID-19 pandemic, the need for hospital admission and mortality is higher in people > 60 years. Therefore, this is a target population to try to reduce the serious complications and lethality of COVID pneumonia and to avoid overloading the hospital system. Given the pharmacological properties of colchicine (anti-inflammatory and anti-fibrotic, possible inhibition of viral replication, and inhibitory effect on coagulation activation), early treatment with colchicine may reduce the rate of death and serious pulmonary complications from COVID-19 in vulnerable patients. METHODS: The COLCHICOVID study is a randomized, multicenter, controlled, open-label parallel group (2:1 ratio), phase III clinical trial to investigate the efficacy of early administration of colchicine in reducing the development of severe pulmonary complications associated with COVID-19 infection in patients over 60 years of age with at-risk comorbidities. DISCUSSION: This is a pragmatic clinical trial, adapted to usual clinical practice. The demonstration that early administration of colchicine has clinical effectiveness in reducing the complications of SARS-CoV-2 infection in a population highly susceptible may mitigate the health crisis and prevent the collapse of the health system in the successive waves of the coronavirus pandemic. In addition, colchicine is a well-known medicine, simple to use in the primary care setting and with a low cost for the health system. TRIAL REGISTRATION: ClinicalTrials.gov NCT04416334 . Registered on 4 June 2020. Protocol version: v 3.0, dated 22 September 2020.


Subject(s)
COVID-19 , SARS-CoV-2 , Aged , Colchicine/adverse effects , Humans , Middle Aged , Multicenter Studies as Topic , Pandemics , Primary Health Care , Randomized Controlled Trials as Topic , Treatment Outcome
11.
Int J Immunopathol Pharmacol ; 35: 20587384211031763, 2021.
Article in English | MEDLINE | ID: covidwho-1305554

ABSTRACT

A recently discovered coronavirus, SARS-CoV-2, caused a global respiratory disease pandemic called COVID-19. Many studies have shown the excessive activation of the innate immune response that leads to the adverse outcomes of COVID-19, and anti-inflammatory drugs are very useful in the treatment and management of this infection. The activities of Colchicine, one of the anti-inflammatory drugs, target several pathways related to excessive inflammation of COVID-19. This study aimed to evaluate the efficacy of Colchicine in the treatment of COVID-19 using a meta-analysis approach. Scopus, Pubmed, Google scholars, Web of Science, and Science direct were used to search all the randomized controlled trials, case-control, and cross-sectional studies that have evaluated the efficacy of Colchicine as a treatment for COVID-19 (up to 28 May 2021). The overall effect of Colchicine versus the control group was determined using a random-effects model meta-analysis where we compared changes (i.e. mean differences-Colchicine group vs Control group) between the two conditions in test scores indicative of hospitalization time (day) and mortality rate. The results illustrated Colchicine therapy is associated with a decreased mortality rate in COVID-19 patients and associated with a decrease in hospitalization time (day) in COVID-19 patients. Present preliminary data shows that Colchicine has a beneficial effect on coronavirus disease care in 2019. Therefore, Colchicine can be a good suggestion in the management of COVID-19.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , COVID-19/drug therapy , Colchicine/therapeutic use , Anti-Inflammatory Agents/adverse effects , COVID-19/diagnosis , COVID-19/mortality , COVID-19/virology , Colchicine/adverse effects , Hospital Mortality , Humans , Length of Stay , Time Factors , Treatment Outcome
14.
RMD Open ; 7(1)2021 02.
Article in English | MEDLINE | ID: covidwho-1066938

ABSTRACT

OBJECTIVE: To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes. DESIGN: We present the results of a randomised, double-blinded, placebo-controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 75 patients allocated 1:1 from 11 April to 30 August 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The primary endpoints were the need for supplemental oxygen, time of hospitalisation, need for admission and length of stay in intensive care unit and death rate. RESULTS: Seventy-two patients (36 for placebo and 36 for colchicine) completed the study. Median (and IQR) time of need for supplemental oxygen was 4.0 (2.0-6.0) days for the colchicine group and 6.5 (4.0-9.0) days for the placebo group (p<0.001). Median (IQR) time of hospitalisation was 7.0 (5.0-9.0) days for the colchicine group and 9.0 (7.0-12.0) days for the placebo group (p=0.003). At day 2, 67% versus 86% of patients maintained the need for supplemental oxygen, while at day 7, the values were 9% versus 42%, in the colchicine and the placebo groups, respectively (log rank; p=0.001). Two patients died, both in placebo group. Diarrhoea was more frequent in the colchicine group (p=0.26). CONCLUSION: Colchicine reduced the length of both, supplemental oxygen therapy and hospitalisation. The drug was safe and well tolerated. Once death was an uncommon event, it is not possible to ensure that colchicine reduced mortality of COVID-19. TRIAL REGISTRATION NUMBER: RBR-8jyhxh.


Subject(s)
COVID-19/drug therapy , Colchicine/administration & dosage , Length of Stay , Oxygen Inhalation Therapy , SARS-CoV-2/genetics , Severity of Illness Index , Adult , Aged , COVID-19/mortality , COVID-19/virology , Colchicine/adverse effects , Diarrhea/chemically induced , Double-Blind Method , Female , Humans , Intensive Care Units , Male , Middle Aged , Reverse Transcriptase Polymerase Chain Reaction , Time Factors , Treatment Outcome
16.
Am J Cardiovasc Drugs ; 21(5): 499-512, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-996493

ABSTRACT

Hyperuricemia and gout have been linked to an increased risk for cardiovascular (CV) disease, stroke, hypertension, heart failure, and chronic kidney disease, possibly through a proinflammatory milieu. However, not all the drugs used in gout treatment improve CV outcomes; colchicine has shown improved CV outcomes in patients with recent myocardial infarction and stable coronary artery disease independent of lipid-lowering effects. There is resurging interest in colchicine following publication of the COLCOT, LoDoCo, LoDoCo2, LoDoCo-MI trials, and COLCORONA trial which will shed light on its utility in COVID-19. Our aim is to review the CV use of colchicine beyond pericardial diseases, as well as CV outcomes of the available gout therapies, including allopurinol and febuxostat. The CARES trial and its surrounding controversies, which lead to the US FDA 'black box' warning on febuxostat, in addition to the recent FAST trial which contradicts this and finds febuxostat to be non-inferior, are discussed in this paper.


Subject(s)
Cardiovascular Diseases/complications , Colchicine/therapeutic use , Gout Suppressants/therapeutic use , Gout/drug therapy , Gout/etiology , COVID-19 , Colchicine/adverse effects , Febuxostat/adverse effects , Febuxostat/therapeutic use , Gout Suppressants/adverse effects , Humans , Hyperuricemia/drug therapy , Hyperuricemia/etiology , Pandemics
17.
Semin Arthritis Rheum ; 51(1): 101-112, 2021 02.
Article in English | MEDLINE | ID: covidwho-989220

ABSTRACT

OBJECTIVE: Colchicine has been used historically as an anti-inflammatory agent for a wide range of diseases. Little is known regarding the relationship between colchicine use and infectious disease outcomes. The objective of this study was to systematically examine infectious adverse events associated with colchicine usage and the clinical use of colchicine for infectious diseases. METHODS: A systematic review was conducted in accordance with PRISMA methodology. PubMed, EMBASE, Scopus and Cochrane Library databases were searched (up to 12th October, 2020) for interventional and observational studies that included colchicine usage associated with infectious adverse events or infectious disease outcomes. RESULTS: A total of 9,237 studies were initially identified and after exclusions, 36 articles comprising 21 interventional studies and 15 observational studies were included in this systematic review. There were 19 studies that reported infectious adverse events and 17 studies that examined the efficacy of colchicine in treating infectious disease. Only two out of six studies reported a significant benefit using colchicine in the management of viral liver disease. There was some evidence colchicine is beneficial in managing COVID-19 by reducing time to deterioration, length of stay in hospital and mortality. Colchicine had some benefit in managing malaria, condyloma accuminata and verruca vulgaris, viral myocarditis and erythema nodosum leprosum based on case-series or small, pilot clinical studies. Two of the clinical trials and five of the observational studies reported significant associations between infections adverse events and colchicine usage. Risk of pneumonia was found in three studies and post-operative infections were reported in two studies. Risks of urinary tract infections, H. pylori and C.difficile were only reported by one study each. CONCLUSION: There is a current lack of clinical evidence that colchicine has a role in treating or managing infectious diseases. Preliminary studies have demonstrated a possible role in the management of COVID-19 but results from more clinical trials are needed. There is inconclusive evidence that suggests colchicine is associated with increased risk of infections, particularly pneumonia.


Subject(s)
Anti-Inflammatory Agents/adverse effects , Colchicine/adverse effects , Communicable Diseases/drug therapy , Adult , Anti-Inflammatory Agents/administration & dosage , COVID-19/drug therapy , Colchicine/administration & dosage , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , SARS-CoV-2
18.
J Am Acad Dermatol ; 83(6): 1738-1748, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-845104

ABSTRACT

The new coronavirus, severe acute respiratory syndrome coronavirus 2, is associated with a wide variety of cutaneous manifestations. Although new skin manifestations caused by COVID-19 are continuously being described, other cutaneous entities should also be considered in the differential diagnosis, including adverse cutaneous reactions to drugs used in the treatment of COVID-19 infections. The aim of this review is to provide dermatologists with an overview of the cutaneous adverse effects associated with the most frequently prescribed drugs in patients with COVID-19. The skin reactions of antimalarials (chloroquine and hydroxychloroquine), antivirals (lopinavir/ritonavir, ribavirin with or without interferon, oseltamivir, remdesivir, favipiravir, and darunavir), and treatments for complications (imatinib, tocilizumab, anakinra, immunoglobulins, corticosteroids, colchicine and low molecular weight heparins) are analyzed. Information regarding possible skin reactions, their frequency, management, and key points for differential diagnosis are presented.


Subject(s)
Coronavirus Infections/drug therapy , Drug Eruptions/diagnosis , Pneumonia, Viral/drug therapy , Antimalarials/adverse effects , Antiviral Agents/adverse effects , Betacoronavirus/immunology , Betacoronavirus/pathogenicity , COVID-19 , Colchicine/adverse effects , Coronavirus Infections/complications , Coronavirus Infections/immunology , Coronavirus Infections/virology , Diagnosis, Differential , Drug Eruptions/etiology , Drug Therapy, Combination/adverse effects , Drug Therapy, Combination/methods , Exanthema/diagnosis , Exanthema/immunology , Exanthema/virology , Glucocorticoids/adverse effects , Humans , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/immunology , Pneumonia, Viral/virology , SARS-CoV-2 , Urticaria/diagnosis , Urticaria/immunology , Urticaria/virology
19.
Medicine (Baltimore) ; 99(36): e21911, 2020 Sep 04.
Article in English | MEDLINE | ID: covidwho-752029

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection is a recently emerged viral infection causing predominantly mild upper respiratory symptoms. However, in some instances, it might result in acute respiratory distress syndrome (ARDS) that poses a significant mortality risk. ARDS is postulated to be mediated by a surge of pro-inflammatory cytokines and chemokines, leading to a dysregulated hyper inflammatory response. Colchicine being an anti-inflammatory agent, might mitigate this dysregulated response. Thus, in the absence of therapeutic options available to manage coronavirus disease 2019 (COVID-19), it is imperative to ascertain the effect of colchicine on improving outcomes in COVID-19 patients. METHOD: We will perform a systematic review including a search of the following databases: PubMed, EMBASE, MEDLINE, Clinicaltrials.gov, Cochrane library, and google scholar since inception. We will include randomized controlled trials exploring the effect of colchicine on the efficacy and safety outcomes of COVID-19 patients. Subsequently, we will perform a meta-analysis utilizing the random-effects to ascertain the effect of colchicine on reducing COVID-19 related mortality (primary endpoint) and other efficacy and safety outcomes. RESULTS: Our review results are anticipated in early 2021 (based on the completion of several ongoing randomized controlled trial). Our review results will be published in a peer-reviewed journal. CONCLUSION: This systematic review and meta-analysis, is exploring the effect of colchicine on the efficacy and safety outcomes of COVID-19 patients. If colchicine proved to be effective, it would be a significant milestone in the management of COVID-19, a disease with limited available therapeutic options. PROSPERO REGISTRATION NUMBER: CRD42020191086.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Colchicine/therapeutic use , Coronavirus Infections/drug therapy , Pneumonia, Viral/drug therapy , Anti-Inflammatory Agents/administration & dosage , Anti-Inflammatory Agents/adverse effects , Betacoronavirus , COVID-19 , Colchicine/administration & dosage , Colchicine/adverse effects , Humans , Pandemics , Randomized Controlled Trials as Topic , Research Design , SARS-CoV-2
20.
Rheumatol Int ; 40(11): 1741-1751, 2020 11.
Article in English | MEDLINE | ID: covidwho-743717

ABSTRACT

Repurposing of antirheumatic drugs has garnered global attention. The aim of this article is to overview available evidence on the use of widely used antirheumatic drugs hydroxychloroquine, methotrexate and colchicine for additional indications. Hydroxychloroquine has endothelial stabilizing and anti-thrombotic effects. Its use has been explored as an adjunctive therapy in refractory thrombosis in antiphospholipid syndrome. It may also prevent recurrent pregnancy losses in the absence of antiphospholipid antibodies. Hydroxychloroquine favourably modulates atherogenic lipid and glycaemic profiles. Methotrexate has been tried for modulation of cardiovascular events in non-rheumatic clinical conditions, although a large clinical trial failed to demonstrate a benefit. Colchicine has been shown to successfully reduce the risk of recurrent cardiovascular events in a large multicentric trial. Potential antifibrotic effects of colchicine require further exploration. Hydroxychloroquine, methotrexate and colchicine are also being tried at different stages of the ongoing Coronavirus Disease 19 (COVID-19) pandemic for prophylaxis and treatment. While the use of these agents is being diversified, their adverse effects should be timely diagnosed and prevented. Hydroxychloroquine can cause retinopathy and rarely cardiac and auditory toxicity, retinopathy being dose and time dependent. Methotrexate can cause transaminitis, cytopenias and renal failure, particularly in acute overdoses. Colchicine can rarely cause myopathies, cardiomyopathy, cytopenias and transaminitis. Strong evidence is warranted to keep balance between benefits of repurposing these old antirheumatic drugs and risk of their adverse effects.


Subject(s)
Antirheumatic Agents/therapeutic use , Betacoronavirus , Colchicine/therapeutic use , Coronavirus Infections/drug therapy , Drug Repositioning , Hydroxychloroquine/therapeutic use , Methotrexate/therapeutic use , Pneumonia, Viral/drug therapy , COVID-19 , Colchicine/adverse effects , Hydroxychloroquine/adverse effects , Methotrexate/adverse effects , Pandemics , SARS-CoV-2
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