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Trial - NCT04669015


Column Value
Trial registration number NCT04669015
Full text link
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04669015

First author
Last imported at : Feb. 17, 2022, 5 p.m.
Source : ClinicalTrials.gov

Huimei Huang

Contact
Last imported at : Feb. 17, 2022, 5 p.m.
Source : ClinicalTrials.gov

hhuang@genova.cn

Registration date
Last imported at : Dec. 19, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-16

Recruitment status
Last imported at : June 24, 2021, 2 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

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

multi-center

Study aim
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 4, 2022, 2 p.m.
Source : ClinicalTrials.gov

inclusion criteria: inclusion criteria: signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures. men and women, ≥18 years of age at time of enrollment. laboratory-confirmed diagnosis of sars-cov-2 infection as determined by pcr, or other health authority-approved commercial assay or other validated public health assay in any specimen within 72 hours prior to randomization (point-of-care viral infection test allowable if rt-pcr test result not available only at the time of screening). less than or equal to 9 days from covid-19 symptom onset to starting treatment. • symptoms are defined as one or more of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, chills/sweating, headache, confusion, sore throat, runny nose/congestion, loss of taste or smell, or any other covid-19 symptoms as determined by the investigator. hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii) non-invasive ventilation or iii) high-flow oxygen (who category 4 or 5) female patients participating in this study must agree to avoid becoming pregnant and have a negative pregnancy test prior to randomization. male and female patients of reproductive potential must use a highly effective, protocol-specified method of contraception during the study and up to post 30 days after the last dose of study drug. for a list of protocol-specified contraceptive methods, and the definition of reproductive potential, refer to appendix 1.

Exclusion criteria
Last imported at : June 4, 2022, 2 p.m.
Source : ClinicalTrials.gov

Number of arms
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Genova Inc.

Inclusion age min
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : June 4, 2022, 2 p.m.
Source : ClinicalTrials.gov

Argentina;Brazil;Canada;Chile;Colombia;Indonesia;Kenya;Malaysia;Peru;South Africa;Turkey;Ukraine

Type of patients
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

914

primary outcome
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Rate of clinical deterioration

Notes
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Phase 3

Arms
Last imported at : Dec. 18, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 911, "treatment_name": "Novaferon", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]