COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04382040


Column Value
Trial registration number NCT04382040
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04382040

First author
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Rubi Zomer

Contact
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Nadia Lisovoder, nadyal@galilee-cbr.com (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-11

Recruitment status
Last imported at : March 5, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: confirmed sars-cov-2 infection. hospitalized covid-19 patient in stable moderate condition (i.e., not requiring icu admission). subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

tube feeding or parenteral nutrition. patients who are symptomatic and require oxygen (ordinal scale for clinical improvement score >3) at the time of screening. respiratory decompensation requiring mechanical ventilation. uncontrolled diabetes type 2. autoimmune disease. pregnant or lactating women. any condition which, in the opinion of the principal investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

MGC Pharmaceuticals d.o.o

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

India;Israel

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3: Moderate disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

50

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours in comparison to routine treatment;Percentage of participants with definite or probable drug related adverse events

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2249, "treatment_name": "Artemisinin+curcumin+frankincense+vitamin c", "treatment_type": "Antimalarials+vitamins and dietary supplements+others non pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment+non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]