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A randomised, open, controlled trial for darunavir/cobicistat or Lopinavir/ritonavir combined with thymosin a1 in the treatment of novel coronavirus pneumonia (COVID-19)

A randomised, open, controlled trial for darunavir/cobicistat or Lopinavir/ritonavir combined with thymosin a1 in the treatment of novel coronavirus pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029541
Enrollment
Unknown
Registered
2020-02-03
Start date
2020-02-10
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

DRV/c group:DRV/c (800mg/150mg QD) + Conventional treatment containing thymosin (1.6 mg SC QOD)
LPV/r group:LPV/r (400mg/100mg bid) + Conventional treatment containing thymosin (1.6 mg SC QOD)
other group:Conventional treatment containing thymosin (1.6 mg SC QOD)

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. been Confirmed with 2019-nCoV pneumonia, hospitalized or will be hospitalized; 3. Sign the ICF; 4. no more than 10 days from the occurrence of relevant clinical symptoms to the diagnosis been confirmed.

Exclusion criteria

Exclusion criteria: 1. Allergic history to study medicines; 2. ALT/AST >5 UNL or Child-Pugh Class C; 3. Severely ill patients with life expectance <48 hours; 4. Contraindication of DRV or thymosin; 5. Pregnancy testing positive for child-bearing woman; 6. Known HIV infection; 7. not adequate to be enrolled.

Design outcomes

Primary

MeasureTime frame
Time to conversion of 2019-nCoV RNA result from RI sample;—

Secondary

MeasureTime frame
all cause mortality;Time to temperature recovery;Time to improvement of respiratory symptom/signs;Length of hospitalization/ICU stay;Usage of oxygen therapy, mechanical ventilation;;improvement of CT lung imaging;inflammatory biomarkers recovery;—

Countries

China

Contacts

Public ContactWang Xinghuan/Ke Hengning

Zhongnan Hospital of Wuhan University

wangxinghuan@whu.edu.cn+86 18971387168/+86 15729577635

Outcome results

None listed

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