A Pilot Study of Sildenafil in COVID-19

NCT ID: NCT04304313

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-09

Study Completion Date

2020-11-09

Brief Summary

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

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sildenafil citrate tablets

Group Type EXPERIMENTAL

Sildenafil citrate tablets

Intervention Type DRUG

0.1g/day for 14 days

Interventions

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Sildenafil citrate tablets

0.1g/day for 14 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qin Ning

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department and Institute of Infectious Disease

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qing Ning, Professor

Role: CONTACT

+8613971521450

Meifang Han, Professor

Role: CONTACT

+8613986093605

Facility Contacts

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Qin Ning, professor

Role: primary

Meifang Han, professor

Role: backup

References

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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.

Reference Type DERIVED
PMID: 33240091 (View on PubMed)

Other Identifiers

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GST-G1

Identifier Type: -

Identifier Source: org_study_id

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