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Effect of colchicine and aspirin given together in patients with moderate COVID-19

Sunil Naik et al., Contemporary Clinical Trials Communications, doi:10.1016/j.conctc.2023.101070, CTRI/2021/03/032060
Jan 2023  
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Mortality -169% Improvement Relative Risk Progression -108% Recovery, ordinal score 7% Recovery, ordinal ≤1 15% Recovery, CT score 24% Colchicine  Sunil Naik et al.  LATE TREATMENT  RCT Is late treatment with colchicine beneficial for COVID-19? RCT 105 patients in India Trial underpowered for serious outcomes c19early.org Sunil Naik et al., Contemporary Clinic.., Jan 2023 Favorscolchicine Favorscontrol 0 0.5 1 1.5 2+
Colchicine for COVID-19
5th treatment shown to reduce risk in September 2020, now with p = 0.00000031 from 56 studies.
Lower risk for mortality, ICU, hospitalization, and recovery.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
RCT 122 hospitalized patients in India, showing improved recovery with colchicine treatment. All patients received aspirin. There was one death and higher progression in the colchicine arm, however 3 patients in the colchicine arm had baseline ordinal scores ≥5, while no patients in the control arm did.
risk of death, 169.4% higher, RR 2.69, p = 1.00, treatment 1 of 62 (1.6%), control 0 of 43 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of progression, 108.1% higher, RR 2.08, p = 0.64, treatment 3 of 62 (4.8%), control 1 of 43 (2.3%).
recovery, 7.3% lower, RR 0.93, p = 0.21, treatment 62, control 43, relative improvement in ordinal score.
risk of no recovery, 15.0% lower, RR 0.85, p = 0.06, treatment 49 of 62 (79.0%), control 40 of 43 (93.0%), NNT 7.1, ordinal score ≤1.
recovery, 24.3% lower, RR 0.76, p = 0.02, treatment 62, control 43, relative improvement in CT score.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sunil Naik et al., 21 Jan 2023, Randomized Controlled Trial, India, peer-reviewed, 3 authors, trial CTRI/2021/03/032060. Contact: rmg.trial21@gmail.com.
This PaperColchicineAll
Effect of colchicine and aspirin given together in patients with moderate COVID-19
K Sunil Naik, Niranjan Andhalkar, Sohal Pendse
Contemporary Clinical Trials Communications, doi:10.1016/j.conctc.2023.101070
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Declaration of interests ☐ The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ☒The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The study has been funded by ROMEG therapeutics LLC n but there is no financial interest to disclose related to trial results and manuscript writing/reviewing/publishing. J o u r n a l P r e -p r o o f
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Late treatment
is less effective
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