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0 0.5 1 1.5 2+ Mortality -169% Improvement Relative Risk Progression -108% Recovery, ordinal score 7% Recovery, ordinal ≤1 15% Recovery, CT score 24% c19early.org/o Sunil Naik et al. CTRI/2021/03/032060 Colchicine RCT LATE Favors colchicine Favors control
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
Sunil Naik et al., Effect of colchicine and aspirin given together in patients with moderate COVID-19, Contemporary Clinical Trials Communications, doi:10.1016/j.conctc.2023.101070, CTRI/2021/03/032060
Jan 2023   Source   PDF  
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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.
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Abstract: Journal Pre-proof Effect of colchicine and aspirin given together in patients with moderate COVID-19 K. Sunil Naik, Niranjan Andhalkar, Sohal Pendse PII: S2451-8654(23)00016-9 DOI: https://doi.org/10.1016/j.conctc.2023.101070 Reference: CONCTC 101070 To appear in: Contemporary Clinical Trials Communications Received Date: 2 July 2022 Revised Date: 17 December 2022 Accepted Date: 14 January 2023 Please cite this article as: K. Sunil Naik, N. Andhalkar, S. Pendse, Effect of colchicine and aspirin given together in patients with moderate COVID-19, Contemporary Clinical Trials Communications (2023), doi: https://doi.org/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. © 2023 Published by Elsevier Inc. Title: Effect of Colchicine and Aspirin given together in Patients with Moderate COVID19 Authors: aDr. K. Sunil Naik, bMr. Niranjan Andhalkar, bMr. Sohal Pendse a. Research wing, second floor, beside FM ward, Government General Hospital, Srikakulam, Andhra Pradesh – 532001, India. b. 102 A/B, Park Plaza, Main Karve Nagar Chowk, Karve Nagar, Pune, Maharashtra 411052, India. f *Correspondence: -p ro o Mr. Sohal Pendse Postal Address: 102 A/B, Park Plaza, Main Karve Nagar Chowk, Karve Nagar, Pune, Jo ur na Abstract: lP Email: rmg.trial21@gmail.com re Maharashtra 411052, India. Background: The objective of the study was to evaluate the effect of Colchicine 0.5 mg. and Aspirin 75 mg. oral tablets given together on management of moderate COVID-19. Methods: The study was carried out in 122 moderate COVID-19 patients between ages 40 to 80 years in hospital, instructed to take either 1 tablet of Colchicine 0.5 mg. and Aspirin 75 mg. each (treatment group), or 1 tablet of Aspirin 75 mg (Control group), twice a day along with standard of care. Result: At the end of treatment, reduction was seen in the treatment group in score of 8-point ordinal scale, troponin, D-Dimer, Hs-CRP from baseline. There was a fall of 51.1% among control arm and 53.4% among treatment arm in 8-point ordinal score. The reduction in mean D-Dimer was 37% in control group and 38.1% in treatment group. The mean reduction in CT severity score in control group was 3.65 and in treatment group was 4.82, and the difference between the two groups was statistically significant (P value= 0.018) Conclusion: It was evident from CT scan scores that the treatment group has shown significant improvement in the reduction of inflammation and other COVID-19 symptoms as compared to the control group. The fall in Ferritin, Hs-CRP and D-Dimer level after treatment were indicative of improvement in internal inflammatory response of body in COVID-19 disease. As increased troponin levels indicate some degree of heart damage, the fall in troponin levels indicated that test treatment improved heart health in COVID-19 f patients. -p ro o CTRI/2021/03/032060 Keywords: COVID-19, Anti-inflammatory, Cardiac inflammation, NEWS, 8- point..
Late treatment
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