A Pilot Study of Sildenafil in COVID-19

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

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

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Sildenafil citrate tablets

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Department and Institute of Infectious Disease

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of no fever		14 days
Rate of respiratory symptom remission		14 days
Rate of lung imaging recovery		14 days
Rate of C-reactive protein (CRP) 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	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
Rate of adverse event	All adverse events will be coded and described using the International Medical Terms Dictionary (MedDRA).	14 days

Collaborators and Investigators

• Sponsor: Tongji Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2020
• Primary Completion (Actual): March 1, 2020
• Study Completion (Anticipated): November 9, 2020

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: GST-G1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No