A Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）

NCT04425772 | Unknown DMC

• 1 other identifier: FNC-Hope4
• Study Type: interventional
• Target: 342
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of azvudine in treatment of COVID-19

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Change (reduction) in viral load from baseline

  (reduction) in viral load from baseline

  On day 7 and 14

Secondary Outcomes (11)

• proportion of subjects change from mild or moderate type to severe type

  up to 21 days

• proportion of subjects change from severe type to critical type

  up to 21 days

• novel coronavirus nucleic acid conversion rate

  up to 21 days

• Novel coronavirus nucleic acid negative conversion time

  up to 21 days

• The time and proportion of improvement in pulmonary imaging

  up to 21 days

Study Arms (2)

Experimental Group

EXPERIMENTAL

FNC+Standard of Care

Drug: FNC+Standard of Care

Control Group

PLACEBO COMPARATOR

FNC dummy tablet+ Standard of Care

Drug: FNC dummy tablet+Standard of Care

Interventions

FNC+Standard of Care DRUG

FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria

Also known as: Azvudine+SOC

Experimental Group

FNC dummy tablet+Standard of Care DRUG

FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria

Also known as: Azvudin dummy tablet+SOC

Control Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years old, gender not limited;
• Laboratory (RT-PCR) confirmed COVID-19;
• the time from the first positive nucleic acid test to randomization does not exceed more than 4 days;
• informed consent has been signed.

You may not qualify if:

• known or suspected allergies to the components of azivudine tablets;
• according to the latest version of the National Health and Medical Commission Diagnostic criteria of COVID-19, patients with severe novel coronavirus pneumonia was confirmed;
• severe liver disease (TBIL\>=2 times normal upper limit; ALTAST\>=5 times normal upper limit);
• subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
• subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally;
• subjectsis currently receiving anti-hiv treatment;
• women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial;
• participating in other clinical trials or using experimental drugs, except traditional Chinese medicine;
• Other conditions that not appropriate to be enrolled into this study based on investigator's advise.

Sponsors & Collaborators

• Henan Genuine Biotech Co., Ltd.: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: June 11, 2020
• Study Start: June 12, 2020
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06