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Trial - NCT04871633


Column Value
Trial registration number NCT04871633
Full text link
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

2021-05-04

Recruitment status
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 5, 2021, 11:25 a.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 : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Treatment

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

inclusion criteria: all patients with confirmed covid-19 of either gender and aged 12 years and above. patients having severe covid 19 disease. severe disease is defined as patients with an oxygen saturation (spo2) ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ecmo).17 -

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

known severe allergic reaction to remdesivir or to other antiviral drugs patients already having other treatments like tocilizumab or other antiviral drugs pregnancy or breastfeeding alanine aminotransferase (alt) or aspartate aminotransferase (ast) >5 times upper normal limit creatinine clearance <30ml/min low platelet count <50,000/l

Number of arms
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

King Edward Medical University

Inclusion age min
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

12

Inclusion age max
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Pakistan

Type of patients
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

66

primary outcome
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Hospital Stay;Ventilation

Notes
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

None

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

Not reported

Arms
Last imported at : May 5, 2021, 11:25 a.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"}]