Back to resultsA Pilot Study of Sildenafil in COVID-19
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sildenafil citrate tablets
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed as COVID-19:
- mild patient: fever,respiratory and other symptoms, the manifestation of pneumonia can be seen on imaging.
- 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.
- Age≥18 years old,unlimited gender.
- 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).
- Willing to participate in this study,signed Informed Consent and willing to participate in regular follow-up during the study.
Exclusion Criteria:
- Suffer from severe cognitive impairment or mental illness.
- Pregnant and lactating women.
- Patients taking nitric oxide drugs and nitrates in any dosage form.
- 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.
- Patients who are allergic to the study drug or the researcher believes it is not appropriate.
- Participate in other clinical studies at the same time.
Sites / Locations
- Department and Institute of Infectious DiseaseRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sildenafil citrate tablets
Arm Description
Outcomes
Primary Outcome Measures
Rate of disease remission
fever,cough and other symptoms relieved with improved lung CT;
SPO2>93% or PaO2/FiO2 >300mmHg without oxygen inhalation.
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.
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.
Secondary Outcome Measures
Rate of no fever
Rate of respiratory symptom remission
Rate of lung imaging recovery
Rate of C-reactive protein (CRP) recovery
Rate of Biochemical criterion (CK, ALT, Mb) recovery
Rate of undetectable viral RNA (continuous twice)
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.
Rate of adverse event
All adverse events will be coded and described using the International Medical Terms Dictionary (MedDRA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04304313
Brief Title
A Pilot Study of Sildenafil in COVID-19
Official Title
A Pilot Study of Sildenafi in the Treatment of COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 9, 2020 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
November 9, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil citrate tablets
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sildenafil citrate tablets
Intervention Description
0.1g/day for 14 days
Primary Outcome Measure Information:
Title
Rate of disease remission
Description
fever,cough and other symptoms relieved with improved lung CT;
SPO2>93% or PaO2/FiO2 >300mmHg without oxygen inhalation.
Time Frame
14 days
Title
Rate of entering the critical stage
Description
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.
Time Frame
14 days
Title
Time of entering the critical stage
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Rate of no fever
Time Frame
14 days
Title
Rate of respiratory symptom remission
Time Frame
14 days
Title
Rate of lung imaging recovery
Time Frame
14 days
Title
Rate of C-reactive protein (CRP) recovery
Time Frame
14 days
Title
Rate of Biochemical criterion (CK, ALT, Mb) recovery
Time Frame
14 days
Title
Rate of undetectable viral RNA (continuous twice)
Time Frame
14 days
Title
Time for hospitalization
Description
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.
Time Frame
14 days
Title
Rate of adverse event
Description
All adverse events will be coded and described using the International Medical Terms Dictionary (MedDRA).
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed as COVID-19:
mild patient: fever,respiratory and other symptoms, the manifestation of pneumonia can be seen on imaging.
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.
Age≥18 years old,unlimited gender.
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).
Willing to participate in this study,signed Informed Consent and willing to participate in regular follow-up during the study.
Exclusion Criteria:
Suffer from severe cognitive impairment or mental illness.
Pregnant and lactating women.
Patients taking nitric oxide drugs and nitrates in any dosage form.
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.
Patients who are allergic to the study drug or the researcher believes it is not appropriate.
Participate in other clinical studies at the same time.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Ning, Professor
Phone
+8613971521450
Email
qning@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meifang Han, Professor
Phone
+8613986093605
Email
mfhan@foxmail.com
Facility Information:
Facility Name
Department and Institute of Infectious Disease
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Ning, professor
Email
qning@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Meifang Han, professor
Email
mfhan@foxmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33240091
Citation
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.
Results Reference
derived
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A Pilot Study of Sildenafil in COVID-19
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