Effectiveness of early-treatment interventions on self-reported long COVID: A multi-arm, multi-stage adaptive platform control trial

Author:

Reis Gilmar1,Wilson Lindsay2,Ayers Dieter2,Silva Eduardo3,Medeiros Daniela3,Thabane Lehana4,Campos Vitoria3,Ferreira Thiago3,Santos Castilho dos3,Nogueira Ana Maria5,Almeida Ana Paula6,Savassi Leonardo5,Neto Adhemar7,Rocha Ana Carolina1,Bitarães Carina6,Milagres Aline6,Callegari Eduardo6,Simplicio Maria1,Ribeiro Luciene1,França Carla1,Oliveira Rosemary1,Forrest Jamie2,Harari Ofir8,Ruton Hinda8,Sprague Sheila4,McKay Paula4,Guo Christina2,Silva Josue2,Guyatt Gordon9,Rayner Craig10,Dybul Mark11,Glenn Jeffrey S12,Mills Edward4

Affiliation:

1. CardResearch

2. Platform Life Sciences

3. Card Research

4. McMaster University

5. Ouro Preto Federal University

6. City of Ibirité

7. City of Montes Claros

8. Cytel Inc

9. McMaster University, Hamilton, ON

10. Certara Inc

11. Georgetown University

12. Stanford University

Abstract

Abstract Approximately 20% of people infected with COVID-19 develop at least one persistent condition potentially attributable to their SARS-CoV-2 infection. We sought to determine the effectiveness of early COVID-19 treatment interventions on long COVID symptoms. We conducted a multi-arm multi-stage adaptive platform trial at 12 public health clinics in Brazil between June 2020 and July 2022. Participants were followed for 60. Patients received one of six interventions (doxazosin, fluvoxamine, fluvoxamine in combination with inhaled budesonide, interferon-lambda, ivermectin, or metformin) or matching placebo. The primary outcome was persistence of COVID-19 symptoms at 60 days after randomization. We analyzed data from 5,700 participants across study cohorts. Overall, approximately 22% of patients reported at least one ongoing symptom 60 days after randomization, regardless of the early treatment they received. At day 60, we did not find any statistical benefit of any intervention on recovery, cure fractions, or PROMIS scores (mental and physical).

Publisher

Research Square Platform LLC

Reference22 articles.

1. WHO Coronavirus (COVID-19) Dashboard. https://covid19.who.int.

2. Count the cost of disability caused by COVID-19;Briggs A;Nature,2021

3. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact;Davis HE;eClinicalMedicine,2021

4. CDC. Post-COVID Conditions. Centers for Disease Control and Prevention https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html (2022).

5. More than 50 long-term effects of COVID-19: a systematic review and meta-analysis;Lopez-Leon S;Sci Rep,2021

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