COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05195749

Khetam Hussein

Not reported

2022-01-19

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: patients willing and able to provide voluntary written informed consent and to follow the protocol specific requirements. male or female patients over 18 years old. patients with positive rt-pcr test for sars-cov-2 in nasopharyngeal or oropharyngeal swabs (sample collected within 7 days prior to enrollment) who are admitted or being admitted to the hospital for a primary diagnosis of covid-19. in the case of female patients of child-bearing potential, a negative blood pregnancy test prior to beginning the therapy. patients intended to be hospitalized to receive soc including dexamethasone treatment for covid-19.

2

101 Therapeutics

18

100

Israel

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

3

To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 10.;To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 2.;To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 3.;To assess the safety of '005 in moderate to severe COVID-19 patients with Standard of Care treatment at day 4.

None

Phase 2

[{"arm_notes": "", "treatment_id": 2124, "treatment_name": "101-pgc-005 ('005)", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]