A Pilot Study of Sildenafil in COVID-19

Phase 3

• Conditions: COVID-19
• Interventions: Drug: Sildenafil citrate tablets

• Registration Number: NCT04304313
• Lead Sponsor: Tongji Hospital

Brief Summary

Observe the efficacy and safety of G1(Sildenafil citrate tablets) in patients with COVID-19 under clinical actual diagnosis and treatment conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-09
• Study First Submitted: 2020-02-14
• Status Verified: 2020-03
• Primary Completion: 2020-03-01
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-11
• Last Update Submitted: 2020-03-14
• Last Update Posted: 2020-03-17
• Study Completion: 2020-11-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients diagnosed as COVID-19:

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

2. Age≥18 years old,unlimited gender.

3. 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).

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

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 6 months;hereditary pigmented retinitis;heart failure or unstable angina pectoris of coronary heart disease;patients with severe hypotension and hypertension.
5. Patients who are allergic to the study drug or the researcher believes it is not appropriate.
6. Participate in other clinical studies at the same time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sildenafil citrate tablets	Sildenafil citrate tablets	-

Primary Outcome Measures

Name	Time	Method
Rate of disease remission	14 days	1. fever,cough and other symptoms relieved with improved lung CT; 2. SPO2\>93% or PaO2/FiO2 \>300mmHg without oxygen inhalation.
Rate of entering the critical stage	14 days	Comply with any of the followings: 1. Respiratory failure occurs and requires mechanical ventilation; 2. Shock; 3. Patients combined with other organ failure need ICU monitoring and treatment.
Time of entering the critical stage	14 days	Comply with any of the followings: 1. Respiratory failure occurs and requires mechanical ventilation; 2. Shock; 3. Patients combined with other organ failure need ICU monitoring and treatment.

Secondary Outcome Measures

Name	Time	Method
Rate of lung imaging recovery	14 days
Rate of Biochemical criterion (CK, ALT, Mb) recovery	14 days
Rate of undetectable viral RNA (continuous twice)	14 days
Time for hospitalization	14 days	From the date of enrollment to the time when the subject is released from the hospital or transferred to the corresponding department for treatment of other diseases according to the condition.
Rate of no fever	14 days
Rate of respiratory symptom remission	14 days
Rate of C-reactive protein (CRP) recovery	14 days
Rate of adverse event	14 days	All adverse events will be coded and described using the International Medical Terms Dictionary (MedDRA).

Trial Locations

Locations (1)

Department and Institute of Infectious Disease; 🇨🇳 Wuhan, Hubei, China