COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04568863

Juan C Figueira, PhD

Germaine Escames, gescames@ugr.es (PI email not reported)

2020-09-29

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - patient, family member or legal guardian has provided written informed consent. - age ε 18 years. - confirmed sars-cov-2 infection with compatible symptoms and a positive rt-pcr. - admission to the icu with acute hypoxemic respiratory failure attributed to sars-cov-2 infection. - icu length of stay of less than 7 days prior to randomization with or without mv and without signs of improvement in respiratory failure (murray score at randomization greater or equal to the murray score at icu admission).

- participant in a different covid-19 study in which the study drug is under clinical development and hasn't been previously authorized for commercialization. - liver enzymes > 5 times the upper normal range. - chronic kidney disease with gfr < 30 ml/min/1.73 m2 (stage 4 or greater) or need for hemodialysis. - pregnancy. a pregnancy test will be performed on every woman younger than 55 years of age prior to inclusion. - terminal surgical or medical illness. - autoimmune disease. - any patient condition that can prevent the study procedures to be carried out at the treating physician's judgement.

2

Pharmamel S.L.

18

100

Spain

Critical disease at enrollment

8: Critical disease at enrollment

18

Mortality

None

Phase 2

[{"arm_notes": "", "treatment_id": 779, "treatment_name": "Melatonin", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]