A Pilot Study of Sildenafil in COVID-19

COVID-19 Clinical Trial

Official title:

A Pilot Study of Sildenafi in the Treatment of COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04304313
• Other study ID #: GST-G1
• Status: Recruiting
• Phase: Phase 3
• Start date: February 9, 2020
• Est. completion date: November 9, 2020

Study information

• Verified date: March 2020
• Source: Tongji Hospital
• Contact: Qing Ning, Professor
• Phone: +8613971521450
• Email: qning[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 9, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Sildenafil citrate tablets
0.1g/day for 14 days

Locations

Country	Name	City	State
China	Department and Institute of Infectious Disease	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of disease remission	fever,cough and other symptoms relieved with improved lung CT; SPO2>93% or PaO2/FiO2 >300mmHg without oxygen inhalation.	14 days
Primary	Rate of entering the critical stage	Comply with any of the followings: Respiratory failure occurs and requires mechanical ventilation; Shock; Patients combined with other organ failure need ICU monitoring and treatment.	14 days
Primary	Time of entering the critical stage	Comply with any of the followings: Respiratory failure occurs and requires mechanical ventilation; Shock; Patients combined with other organ failure need ICU monitoring and treatment.	14 days
Secondary	Rate of no fever		14 days
Secondary	Rate of respiratory symptom remission		14 days
Secondary	Rate of lung imaging recovery		14 days
Secondary	Rate of C-reactive protein (CRP) recovery		14 days
Secondary	Rate of Biochemical criterion (CK, ALT, Mb) recovery		14 days
Secondary	Rate of undetectable viral RNA (continuous twice)		14 days
Secondary	Time for hospitalization	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.	14 days
Secondary	Rate of adverse event	All adverse events will be coded and described using the International Medical Terms Dictionary (MedDRA).	14 days