A Pilot Study of Sildenafil in COVID-19

• ClinicalTrials.gov Identifier: NCT04304313
• Recruitment Status: Unknown
• First Posted: March 11, 2020
• Last Update Posted: March 17, 2020
• Sponsor: Tongji Hospital
• Information provided by (Responsible Party): Qin Ning, Tongji Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: Sildenafil citrate tablets	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Sildenafi in the Treatment of COVID-19
• Actual Study Start Date: February 9, 2020
• Actual Primary Completion Date: March 1, 2020
• Estimated Study Completion Date: November 9, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sildenafil citrate tablets	Drug: Sildenafil citrate tablets; 0.1g/day for 14 days

Outcome Measures

Primary Outcome Measures :

1. Rate of disease remission [ Time Frame: 14 days ]
   1. fever,cough and other symptoms relieved with improved lung CT;
   2. SPO2>93% or PaO2/FiO2 >300mmHg without oxygen inhalation.
2. Rate of entering the critical stage [ Time Frame: 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.
3. Time of entering the critical stage [ Time Frame: 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 :

1. Rate of no fever [ Time Frame: 14 days ]
2. Rate of respiratory symptom remission [ Time Frame: 14 days ]
3. Rate of lung imaging recovery [ Time Frame: 14 days ]
4. Rate of C-reactive protein (CRP) recovery [ Time Frame: 14 days ]
5. Rate of Biochemical criterion (CK, ALT, Mb) recovery [ Time Frame: 14 days ]
6. Rate of undetectable viral RNA (continuous twice) [ Time Frame: 14 days ]
7. Time for hospitalization [ Time Frame: 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.
8. Rate of adverse event [ Time Frame: 14 days ]
   All adverse events will be coded and described using the International Medical Terms Dictionary (MedDRA).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Qing Ning, Professor; +8613971521450; qning@vip.sina.com

Contact: Meifang Han, Professor; +8613986093605; mfhan@foxmail.com

Locations

China, Hubei

Department and Institute of Infectious Disease; Recruiting

Wuhan, Hubei, China, 430030

Contact: Qin Ning, professor qning@vip.sina.com

Contact: Meifang Han, professor mfhan@foxmail.com

Sponsors and Collaborators

Tongji Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.

• Responsible Party: Qin Ning, Professor, Tongji Hospital
• ClinicalTrials.gov Identifier: NCT04304313
• Other Study ID Numbers: GST-G1
• First Posted: March 11, 2020
• Last Update Posted: March 17, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sildenafil Citrate; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Urological Agents