The DAWN antivirals trial: process evaluation of a COVID-19 trial in general practice.
COVID-19
antiviral
primary health care
trial
Journal
BJGP open
ISSN: 2398-3795
Titre abrégé: BJGP Open
Pays: England
ID NLM: 101713531
Informations de publication
Date de publication:
20 Nov 2023
20 Nov 2023
Historique:
received:
09
06
2023
revised:
14
09
2023
accepted:
18
09
2023
medline:
21
11
2023
pubmed:
21
11
2023
entrez:
20
11
2023
Statut:
aheadofprint
Résumé
The DAWN Antivirals trial was a multicentric, randomised placebo-controlled trial evaluating antiviral medication for COVID-19 in general practice. The trial was prematurely terminated because of insufficient recruitment. To explore which factors contributed to the premature termination. General practice in Belgium. Patients were randomized to camostat or placebo (blinded) between June 2021 and July 2022); a third arm evaluating molnupiravir (open label) was opened in March 2022. We analysed available trial data and evaluated trial context, implementation and mechanisms of impact based on semi-structured interviews with trial stakeholders. The trial recruited 44 participants; 19 were allocated to camostat (median age 55 years), 8 to molnupiravir (median age 60 years) and 17 to placebo (median age 56 years). There were no serious adverse events in either group. Most difficulties were related to the pandemic context: disruption to routine clinical services; multiple changes to the service model for COVID-19 patients; overwhelmed clinical staff; delays of trial medication; staff shortages in the sponsor and clinical team. In addition, regulatory approval processes were lengthy and led to additional study procedures. It was felt that the trial started too late, when vaccinations had already begun. The DAWN Antivirals trial was stopped prematurely. Although many barriers were related to the pandemic itself, hurdles such as small and inexperienced sponsor and clinical teams, delays in regulatory processes and research capacity in routine settings could be overcome by established research infrastructure and standardization of processes.
Sections du résumé
BACKGROUND
BACKGROUND
The DAWN Antivirals trial was a multicentric, randomised placebo-controlled trial evaluating antiviral medication for COVID-19 in general practice. The trial was prematurely terminated because of insufficient recruitment.
AIM
OBJECTIVE
To explore which factors contributed to the premature termination.
DESIGN & SETTING
METHODS
General practice in Belgium.
METHOD
METHODS
Patients were randomized to camostat or placebo (blinded) between June 2021 and July 2022); a third arm evaluating molnupiravir (open label) was opened in March 2022. We analysed available trial data and evaluated trial context, implementation and mechanisms of impact based on semi-structured interviews with trial stakeholders.
RESULTS
RESULTS
The trial recruited 44 participants; 19 were allocated to camostat (median age 55 years), 8 to molnupiravir (median age 60 years) and 17 to placebo (median age 56 years). There were no serious adverse events in either group. Most difficulties were related to the pandemic context: disruption to routine clinical services; multiple changes to the service model for COVID-19 patients; overwhelmed clinical staff; delays of trial medication; staff shortages in the sponsor and clinical team. In addition, regulatory approval processes were lengthy and led to additional study procedures. It was felt that the trial started too late, when vaccinations had already begun.
CONCLUSION
CONCLUSIONS
The DAWN Antivirals trial was stopped prematurely. Although many barriers were related to the pandemic itself, hurdles such as small and inexperienced sponsor and clinical teams, delays in regulatory processes and research capacity in routine settings could be overcome by established research infrastructure and standardization of processes.
Identifiants
pubmed: 37984980
pii: BJGPO.2023.0109
doi: 10.3399/BJGPO.2023.0109
pii:
doi:
Types de publication
Journal Article
Langues
eng
Informations de copyright
Copyright © 2023, The Authors.