A Pilot Study of Sildenafil in COVID-19

Last updated: March 14, 2020
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04304313
GST-G1
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Patients diagnosed as COVID-19:

  2. mild patient: fever,respiratory and other symptoms, the manifestation ofpneumonia can be seen on imaging.

  3. severe patients: meet the definition of severe pneumonia(comply with any of thefollowings): Shortness of breath,RR≥30 bpm;In a restingstate:SPO2≤93%;PaO2/FiO2≤300mmHg.

  4. Age≥18 years old,unlimited gender.

  5. Patients who cannot stop the following drugs during the trial:erythromycin or stronginhibitors of CYP3A4 (such as saquinavir,ketoconazole,itraconazole),nonspecificinhibitors of CYP (such as cimetidine),HIV protease inhibitors (such as ritonavir).

  6. Willing to participate in this study,signed Informed Consent and willing toparticipate in regular follow-up during the study.

Exclusion

Exclusion Criteria:

  1. Suffer from severe cognitive impairment or mental illness.

  2. Pregnant and lactating women.

  3. Patients taking nitric oxide drugs and nitrates in any dosage form.

  4. Patients with malignant tumors;AMI, stroke or life-threatening arrhythmias within 6months;hereditary pigmented retinitis;heart failure or unstable angina pectoris ofcoronary heart disease;patients with severe hypotension and hypertension.

  5. Patients who are allergic to the study drug or the researcher believes it is notappropriate.

  6. Participate in other clinical studies at the same time.

Study Design

Total Participants: 10
Study Start date:
February 09, 2020
Estimated Completion Date:
November 09, 2020

Connect with a study center

  • Department and Institute of Infectious Disease

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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