COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04365127

Sara Ghandehari, MD

Vanessa Vasco, Vanessa.Vasco@csmns.org (PI email not reported)

2020-04-28

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: laboratory-confirmed covid-19 with in 72 hours prior to randomization respiratory symptoms or abnormal lung exam or abnormal chest imaging and oxygen saturation ≤94% on room air, or requiring supplemental oxygen less than 50% high flow understands and agrees to comply with planned study procedures agrees to the collection of venous blood per protocol must agree to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (dvt) while hospitalized

alt or ast >5 times the upper limit of normal history of blood clots history of breast cancer allergy to progesterone or betacyclodextrin use of supplemental oxygen prior to hospital admission requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation

2

Sara Ghandehari

18

None

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

40

Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale

None

Phase 1

[{"arm_notes": "", "treatment_id": 1023, "treatment_name": "Progesterone", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]