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Clinical study for safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19)

Clinical study on safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029600
Enrollment
Unknown
Registered
2020-02-06
Start date
2020-01-30
Completion date
Unknown
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

novel coronavirus pneumonia (COVID-19)

Interventions

Group A:alpha-Interferon atomization
Group B:Lopinavir and Ritonavir + alpha-Interferon atomization
Group C:Favipiravir + alpha-Interferon atomization

Sponsors

The Third People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 16 to 75 years of age, male or female; 2. Respiratory or blood samples tested positive for novel coronavirus; 3. Within 7 days of onset: Onset is defined as body temperature exceeding 38 degree C (armpit temperature) or at least one 2019-nCoV pneumonia related systemic or respiratory symptom; 4. Willing to take contraception during the study and within 7 days after treatment; 5. No difficulty in swallowing the Pills; 6. Willing to sign informed consent form.

Exclusion criteria

Exclusion criteria: 1. Any situation which the protocol cannot be carried out safely; 2. Patient refuses to receive invasive tracheal support (if needed); 3. Pregnant or lactating women:childbearing age women with positive pregnancy test, breastfeeding, miscarriage or within 2 weeks after delivery.Postmenopausal and hysterectomy women do not need a pregnancy test; 4. Patients with chronic liver and kidney disease and reaching end-stage; 5. Previous history of allergic reactions to Fapiravir or Lopinavir and Ritonavir; 6. Currently or in the past 28 days, participated in another clinical trial against novel coronavirus treatment; 7. After the investigator's judgment, the subjects could not participate the study protocol, follow-up or self-evaluation after enrollment.

Design outcomes

Primary

MeasureTime frame
Declining speed of Novel Coronavirus by PCR;Negative Time of Novel Coronavirus by PCR;Incidentce rate of chest imaging;Incidence rate of liver enzymes;Incidence rate of kidney damage;

Countries

China

Contacts

Public ContactLiu Yingxia

The Third People's Hospital of Shenzhen

yingxialiu@hotmail.com+86 755 61238922

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026