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All Studies   Meta Analysis    Recent:   

Colchicine and/or Naltrexone for Hospitalized COVID-19 Patients Not Requiring High Levels of Ventilatory Support (COLTREXONE): A Prospective, Randomized, Open-Label Trial

Gertner et al., Cureus, doi:10.7759/cureus.60364, COLTREXONE, NCT04756128
May 2024  
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ICU/stepdown 65% Improvement Relative Risk Recovery 43% Day of recovery 24% primary HFNC/NIPPV 34% Hospitalization time 20% Colchicine  COLTREXONE  LATE TREATMENT  RCT Is late treatment with colchicine beneficial for COVID-19? RCT 137 patients in the USA (January - November 2021) Lower ICU admission (p=0.11) and improved recovery (p=0.14), not sig. c19early.org Gertner et al., Cureus, May 2024 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.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 77 treatments. c19early.org
Open-label RCT 137 hospitalized COVID-19 patients, showing lower progression to ICU/step-down ICU and improved recovery with colchicine, both without statistical significance. The primary outcome was changed mid-trial due to the low number of patients progressing to severe disease.
ICU/stepdown, 65.0% lower, OR 0.35, p = 0.11, treatment 67, control 70, adjusted per study, multivariable, RR approximated with OR.
recovery, 43.2% lower, OR 0.57, p = 0.14, treatment 67, control 70, adjusted per study, inverted to make OR<1 favor treatment, multivariable, day 5, RR approximated with OR.
day of recovery, 24.2% lower, HR 0.76, p = 0.12, treatment 67, control 70, adjusted per study, inverted to make HR<1 favor treatment, multivariable, Cox proportional hazards, primary outcome.
HFNC/NIPPV, 34.0% lower, OR 0.66, p = 0.34, treatment 67, control 70, adjusted per study, multivariable, RR approximated with OR.
hospitalization time, 20.0% lower, relative time 0.80, p = 0.13, treatment 67, control 70, adjusted per study, multivariable.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gertner et al., 15 May 2024, Randomized Controlled Trial, USA, peer-reviewed, mean age 58.0, 8 authors, study period 25 January, 2021 - 29 November, 2021, trial NCT04756128 (history) (COLTREXONE). Contact: elie.x.gertner@healthpartners.com.
This PaperColchicineAll
Colchicine and/or Naltrexone for Hospitalized COVID-19 Patients Not Requiring High Levels of Ventilatory Support (COLTREXONE): A Prospective, Randomized, Open-Label Trial
Elie Gertner, Anne Schullo-Feulner, Alison Knutson, Ella Chrenka, Meghan O'brien, Christine Behrendt, Joseph Johnson, Daniel Delaney
Cureus, doi:10.7759/cureus.60364
We assessed the efficacy and safety of colchicine and low-dose naltrexone (LDN), alone and in combination, in preventing progression to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In this prospective, randomized, open-label trial, colchicine and LDN were compared to standard of care (SOC) in patients hospitalized with SARS-CoV-2 not requiring high levels of ventilatory support. Patients were randomly assigned to colchicine alone, LDN alone, colchicine/LDN in combination, or SOC. The primary outcome was time to disease recovery. Secondary outcomes included total time hospitalized, study enrollment, level of care, oxygen support, and adverse events. One-hundred and thirty-seven patients were randomized (N c = 34, N c+ldn = 33, N ldn = 35, N soc = 35). Eightyfour patients (61%) achieved disease recovery by day 5. There was no significant difference in the proportion of patients who experienced the primary efficacy outcome among those who received colchicine, LDN, or between the four study arms. Patients receiving colchicine had a shorter length of enrollment but not a significant reduction in the length of stay. Diarrhea was the most common adverse reaction. In adults hospitalized with SARS-CoV-2 not requiring high-level ventilatory support, colchicine and LDN, alone and in combination, were not associated with significant reductions in progression to severe disease.
Additional Information Author Contributions All authors have reviewed the final version to be published and agreed to be accountable for all aspects of the work. Concept and design: Elie
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Immun ' 'Inflamm Dis. 2022, 10:255-64. 10.1002/iid3.562', 'journal-title': 'Immun Inflamm Dis'}], 'container-title': 'Cureus', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://www.cureus.com/articles/240800-colchicine-andor-naltrexone-for-hospitalized-covid-19-patients-not-requiring-high-levels-of-ventilatory-support-coltrexone-a-prospective-randomized-open-label-trial', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 5, 15]], 'date-time': '2024-05-15T19:31:44Z', 'timestamp': 1715801504000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://www.cureus.com/articles/240800-colchicine-andor-naltrexone-for-hospitalized-covid-19-patients-not-requiring-high-levels-of-ventilatory-support-coltrexone-a-prospective-randomized-open-label-trial'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2024, 5, 15]]}, 'references-count': 26, 'URL': 'http://dx.doi.org/10.7759/cureus.60364', 'relation': {}, 'ISSN': ['2168-8184'], 'subject': [], 'published': {'date-parts': [[2024, 5, 15]]}}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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