COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04746430

Janwillem Kocks

COPPER@gpri.nl

2021-02-09

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - age ≥18 years - a positive test for sars-cov-2 - a gp consultation for deteriorating covid-19 symptoms additional inclusion criteria in order to be eligible for randomization to the trial: - exercise-induced desaturation, defined as spo2<92% (<90% for copd patients) and/or an absolute drop of ≥4% in spo2 after a 1-minute sit-to-stand test or - spo2<92% (<90% for copd patients) in rest with gp's and patient's shared decision to keep patient at home despite this in itself being an indication for referral to hospital

- inability to understand and sign the written consent form - inability to perform saturation measurements or sit-to-stand test - not willing to be admitted to hospital - on the discretion of the recruiting clinician if he or she deems a patient not eligible the following criterion will be used to exclude patients from randomization to the trial: - contra-indication for dexamethasone

2

General Practitioners Research Institute

18

100

Netherlands

Severe disease at enrollment

6: Severe disease at enrollment

17

Hospitalization/death

None

Phase 4

[{"arm_notes": "Sub-group patient with deteriorating COVID-19 symptoms (Potential trial results for long covid)", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]