Status:
UNKNOWN
A Pilot Study of Sildenafil in COVID-19
Lead Sponsor:
Tongji Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Observe the efficacy and safety of G1(Sildenafil citrate tablets) in patients with COVID-19 under clinical actual diagnosis and treatment conditions
Eligibility Criteria
Inclusion
- Patients diagnosed as COVID-19:
- mild patient: fever,respiratory and other symptoms, the manifestation of pneumonia can be seen on imaging.
- severe patients: meet the definition of severe pneumonia(comply with any of the followings): Shortness of breath,RR≥30 bpm;In a resting state:SPO2≤93%;PaO2/FiO2≤300mmHg.
- Age≥18 years old,unlimited gender.
- Patients who cannot stop the following drugs during the trial:erythromycin or strong inhibitors of CYP3A4 (such as saquinavir,ketoconazole,itraconazole),nonspecific inhibitors of CYP (such as cimetidine),HIV protease inhibitors (such as ritonavir).
- Willing to participate in this study,signed Informed Consent and willing to participate in regular follow-up during the study.
Exclusion
- Suffer from severe cognitive impairment or mental illness.
- Pregnant and lactating women.
- Patients taking nitric oxide drugs and nitrates in any dosage form.
- Patients with malignant tumors;AMI, stroke or life-threatening arrhythmias within 6 months;hereditary pigmented retinitis;heart failure or unstable angina pectoris of coronary heart disease;patients with severe hypotension and hypertension.
- Patients who are allergic to the study drug or the researcher believes it is not appropriate.
- Participate in other clinical studies at the same time.
Key Trial Info
Start Date :
February 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 9 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04304313
Start Date
February 9 2020
End Date
November 9 2020
Last Update
March 17 2020
Active Locations (1)
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1
Department and Institute of Infectious Disease
Wuhan, Hubei, China, 430030