COVID-19Phase 3NCT04304313
A Pilot Study of Sildenafil in COVID-19
A Phase 3 study testing Sildenafil citrate tablets in people with COVID-19, run by Tongji Hospital at 1 site in China.
Trial summary
Observe the efficacy and safety of G1(Sildenafil citrate tablets) in patients with COVID-19 under clinical actual diagnosis and treatment conditions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Sildenafil citrate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2020to 9 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department and Institute of Infectious Disease
Wuhan, Hubei, 430030
Qin Ning, professor, qning@vip.sina.com
Meifang Han, professor, mfhan@foxmail.com
About this study
Official title: 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
- Conditions
- COVID-19
- Being tested
- Sildenafil citrate tablets
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil citrate tabletsDrug
0.1g/day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil citrate tablets | Experimental | Not described Receives: Drug: Sildenafil citrate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of disease remission
- fever,cough and other symptoms relieved with improved lung CT;
- SPO2>93% or PaO2/FiO2 >300mmHg without oxygen inhalation.
Measured: 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.
Measured: 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.
Measured: 14 days
Secondary outcomes (8)
Rate of no fever
Measured: 14 days
Rate of respiratory symptom remission
Measured: 14 days
Rate of lung imaging recovery
Measured: 14 days
Rate of C-reactive protein (CRP) recovery
Measured: 14 days
Rate of Biochemical criterion (CK, ALT, Mb) recovery
Measured: 14 days
Rate of undetectable viral RNA (continuous twice)
Measured: 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.
Measured: 14 days
Rate of adverse event
All adverse events will be coded and described using the International Medical Terms Dictionary (MedDRA).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start9 Feb 2020
- Primary completion1 Mar 2020
- Study completion9 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304313
- Sponsor's protocol ID
- GST-G1
- Status last verified
- Mar 2020
- First submitted
- 14 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33240091
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Sildenafi in the Treatment of COVID-19
- ClinicalTrials.gov ID
- NCT04304313
- Acronym / sponsor ID
- GST-G1
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 9 Nov 2020 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observe the efficacy and safety of G1(Sildenafil citrate tablets) in patients with COVID-19 under clinical actual diagnosis and treatment conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sildenafil citrate tablets | Experimental | Drug: Sildenafil citrate tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed as COVID-19:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil citrate tablets0.1g/day for 14 days | Drug | Sildenafil citrate tablets |
Primary outcome
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.
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.
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.
8 secondary outcomes
Rate of no fever
Time frame: 14 days
Rate of respiratory symptom remission
Time frame: 14 days
Rate of lung imaging recovery
Time frame: 14 days
Rate of C-reactive protein (CRP) recovery
Time frame: 14 days
Rate of Biochemical criterion (CK, ALT, Mb) recovery
Time frame: 14 days
Rate of undetectable viral RNA (continuous twice)
Time frame: 14 days
Time for hospitalization
Time frame: 14 days
Rate of adverse event
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 33240091Sultana 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil citrate tablets in people with COVID-19, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Ning, Professor (+8613971521450, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of disease remission (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304313, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.