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A randomized controlled Trial for therapeutic efficacy of Recombinant Human Interferon alpha 1b Eye Drops in the treatment of elderly with novel coronavirus pneumonia (COVID-19)

A randomized controlled Trial for therapeutic efficacy of Recombinant Human Interferon alpha 1b Eye Drops in the treatment of elderly with novel coronavirus pneumonia (COVID-19)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029989
Enrollment
Unknown
Registered
2020-02-18
Start date
2020-02-20
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

experimental group.:Recombinant Human Interferon a1b Eye Drops
Control group:placebo drop

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=60 years; 2. Patients confirmed with novel coronavirus pneumonia. The Diagnostic criteria refer to "Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"; 3. Those without broad-spectrum antibacterial, antifungal, and antiviral treatment; 4. Imaging revealed pneumonia in patients with a diagnosis of pathogen: influenza, CAP/HAP bacterial infection, and fungal infection; 5. Participants signed informed consent before the study; 6. It must be agreed not to participate in other clinical studies until the 28th day of completion.

Exclusion criteria

Exclusion criteria: 1. critically ill patients based on the New Protocol for Diagnosis and Treatment of NCP; 2. Patients with eye diseases (such as cataract, conjunctivitis, glaucoma) 3. Severe liver disease (such as AST > 3 ULN); 4. Patients with severe renal insufficiency (estimated glomerular filtration rate <=30ml/min/1.73m2) or continuous renal replacement therapy, hemodialysis or peritoneal dialysis; 5. Pregnant or breast-feeding women; 6. Patients may be transferred to non-designated hospitals within 72 hours; 7. Patients who have participated in other clinical trials in the past 7 days; 8. Allergic constitution, such as those who are allergic to two or over twodrugs ,with history of food allergies, or known to be allergic to the ingredients of this drug; 9. In the opinion of the investigator, subjects who are not suitable for enrollment or with any factors that affect the outcome of the trial.

Design outcomes

Primary

MeasureTime frame
Arterial Blood Oxygen Saturation;TTCR,Time to Clinical recovery;temperature;respiratory rate;Lung CT;

Secondary

MeasureTime frame
Frequency of exacerbations of dyspnea ;Antipyretic time;Time to cough relief;Time to relieve dyspnea;The time when the 2019 ncov RT-PCR test of upper respiratory tract samples turned negative;

Countries

China

Contacts

Public ContactFeng Cao

Chinese PLA General Hospital

fengcao8828@163.com+86 13911798280

Outcome results

None listed

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