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Randomized controlled trial for safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19) with poorly responsive ritonavir/ritonavir

Clinical study for safety and efficacy of Favipiravir in the treatment of novel coronavirus pneumonia (COVID-19) with poorly responsive ritonavir/ritonavir

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030113
Enrollment
Unknown
Registered
2020-02-23
Start date
2020-02-22
Completion date
Unknown
Last updated
2020-02-25

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

Control group:Keep ritonavir/ritonavir treatment
Experimental group:Favipiravir

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. A novel coronavirus nucleic acid was detected in respiratory or anal swabs after 10 days of standard treatment with roranavir / ritonavir; 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. 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
Blood routine tests, Liver function examination, Renal function examination, Blood gas analysis, Chest CT examination;

Contacts

Public ContactLiu Yingxia

Shenzhen the 3rd People's Hospital

yingxialiu@hotmail.com+86 755 61238922

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026