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Trial - NCT04596839


Column Value
Trial registration number NCT04596839
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04596839

First author
Last imported at : June 3, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Major General Md. Azizul Islam

Contact
Last imported at : June 3, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

aziz100542@yahoo.com

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

2020-10-22

Recruitment status
Last imported at : Aug. 11, 2021, 4 p.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

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-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: age ≥18 years at time of signing informed consent form hospitalized with diagnosed covid-19 confirmed by rt-pcr test ≤ 7 days before randomization with any one following criteria respiratory distress (≥30 breaths/min); finger oxygen saturation ≤93% at rest; arterial partial pressure of oxygen (pao2)/fraction of inspired oxygen (fio2) ≤300mmhg willingness of study participant to accept randomization to any assigned treatment arm must agree not to enroll in another study of an investigational agent prior to completion of day 28 of study

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

- physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. - severe liver disease (alanine transaminase (alt) or aspartate transaminase (ast) > 5 times the upper limit of normal) - estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). - mechanically ventilated (including v-v ecmo) ≥ 5 days, or any duration of v-a ecmo. - known hypersensitivity to the remdesivir, the metabolites, or formulation excipient - pregnancy or breast feeding. - anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.

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

Dr. Md. Alimur Reza

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

100

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

Bangladesh

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

Severe disease at enrollment

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

6: Severe disease at enrollment

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

60

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

Duration of hospital stay (Days)

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

None

Phase
Last imported at : June 3, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 29, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]