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Trial - NCT05218356


Column Value
Trial registration number NCT05218356
Full text link
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05218356

First author
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Dr NJ Hussen Hussen, Dr

Contact
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

drnazreen@wwct.co.za

Registration date
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

2022-02-01

Recruitment status
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Single group assignment

Masking
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

inclusion criteria: age between 18 and 75 years male or female sars-cov-2 infection indicated by confirmed rt-pcr test moderate hospitalized covid-19 (at least two out of three criterias below): evidence of lower respiratory disease during clinical assessment (cough, fever, difficulty breathing) or imaging (x-rays) oxygen saturation (spo2) in room air < 93% <30 breaths per minute no signs of hemodynamic decompensation absence of pregnancy in women of childbearing age ability to understand and comply with the requirements of the protocol consent to participate consent to use at least one highly effective contraception methods (condoms, iud, oral contraceptives) since the icf signature and at least 30 days after the study.

Exclusion criteria
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

patients receiving oxygen supplementation except of nasal prongs, nasal intermittent positive pressure ventilation (nippv) or high flow nasal cannula (hfnc) that are allowed to be enrolled to the study). positive rt-pcr test more than 72 hours prior to enrolment. onset of symptoms more than 7 days prior to enrolment. participant using drugs that are under clinical investigation in last 30 days. body mass index less than 19.9 or greater than 35. comorbidities such as: other serious infections, active malignancies, autoimmune diseases, liver, kidney or heart failure; another systemic disease and / or laboratory abnormality, which, in the investigator's opinion, prevent the patient from participating in the study. concomitant hiv, hbv or hcv infection. pregnancy or lactation. vaccination for any other infection in the 4 weeks prior to enrolment. any condition that increases the risk of participating in the study, in the opinion of the investigator.

Number of arms
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Code Pharma

Inclusion age min
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

75

Countries
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

South Africa

Type of patients
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

130

primary outcome
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Change in World Health Organization Ordinal Scale for clinical improvement

Notes
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Feb. 2, 2022, 1 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2361, "treatment_name": "Codivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]