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

H

HeNan Sincere Biotech

Status

Unknown

Conditions

COVID-19

Treatments

Drug: FNC dummy tablet+Standard of Care
Drug: FNC+Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT04425772
FNC-Hope4

Details and patient eligibility

About

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

Enrollment

342 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. known or suspected allergies to the components of azivudine tablets;
  2. 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;
  3. severe liver disease (TBIL>=2 times normal upper limit; ALTAST>=5 times normal upper limit);
  4. subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
  5. subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally;
  6. subjectsis currently receiving anti-hiv treatment;
  7. 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;
  8. participating in other clinical trials or using experimental drugs, except traditional Chinese medicine;
  9. Other conditions that not appropriate to be enrolled into this study based on investigator's advise.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

342 participants in 2 patient groups, including a placebo group

Experimental Group
Experimental group
Description:
FNC+Standard of Care
Treatment:
Drug: FNC+Standard of Care
Control Group
Placebo Comparator group
Description:
FNC dummy tablet+ Standard of Care
Treatment:
Drug: FNC dummy tablet+Standard of Care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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