COVIDPhase 4NCT04946162
The Use of Tadalafil in Confirmed COVID-19 Pneumonia.
A Phase 4 study testing Tadalafil Pill in people with COVID and Sars-CoV2, run by Santa Barbara Cottage Hospital.
Trial summary
Our goal is to assess the effects of Tadalafil in the setting of confirmed COVID-19 pneumonia. In particular we plan to assess its effects on oxygen saturation, P:F ratio, and mixed central venous oxygen We plan to recruit all hospitalized patients at Santa Barbara Cottage Hospital with a confirmed COVID19 pneumonia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Sars-CoV2, ARDS, Human
- What is being tested?
- Tadalafil Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2020to 20 Apr 2020
- Phase
- Phase 4
- 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
- Hospitalized patients at SBCH with confirmed COVID19 pneumonia (PCR + clinical signs/symptoms of lower respiratory disease)
- Patients currently on a ventilator
- Patients who meet the Berlin definition of ARDS
- Patients who have access to measure a mixed venous oxygen saturation (i.e., patients with an internal jugular central venous catheter)
- Patient and/or Legally Authorized Representative is willing/able to provide informed consent
Who cannot join
- As tadalafil is currently a FDA Class B1 medication, indicating that little information is available, pregnant women along with women who are actively breastfeeding will be excluded from this series.
- All patients under 18
- Patients who are routinely taking nitrate medications
- All patients using Tadalafil daily for pulmonary arterial hypertension (Note: patients using Tadalafil intermittently for erectile dysfunction may still participate in the study)
About this study
Our goal is to assess the effects of Tadalafil in the setting of confirmed COVID-19 pneumonia. In particular we plan to assess its effects on oxygen saturation, P:F ratio, and mixed central venous oxygen
We plan to recruit all hospitalized patients at Santa Barbara Cottage Hospital with a confirmed COVID19 pneumonia (positive PCR + clinical signs/symptoms of lower respiratory disease) who meet the Berlin definition of ARDS and have access to measure a mixed venous oxygen saturation. For the purposes of obtaining mixed central venous oxygen, all participating patients will already have an internal jugular central venous catheter in place for inclusion in this study. Since all patients will be intubated, their Legally Authorized Representative (LAR) will be approached to discuss the study and asked to participate in the study by an ICU physician, either the attending physician or a medical resident.
Read more
Informed consent will be obtained from the LAR by an ICU attending physician or resident involved in the study prior to participation. Patients who meet the above eligibility criteria will have baseline levels of mixed central venous oxygen, oxygen saturation, P:F ratio, blood pressure and PaO2 recorded.
Each patient will then receive Tadalafil 40mg once. The above listed parameters will be monitored again 30 minutes after drug administration and 4 hours after drug administration. No other medication or ventilator changes will be made during this time period outside of emergent changes in the setting of patient deterioration. We will continue to analyze the data in the event of emergent ventilator changes.
- Conditions
- COVID, Sars-CoV2, ARDS, Human
- Being tested
- Tadalafil Pill
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil PillDrug
Each patient will be given tadalafil 40 mg one time
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil Group | Experimental | Each patient will be given tadalafil 40 mg one time Receives: Drug: Tadalafil Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in P:F ratio
Change in a patient's P:F ratio after medication administration
Measured: Pre-medication, 30 minutes post medication, 4 hours post-medication
Improvement in oxygen saturation
Change in oxyhemoglobin as noted on an arterial blood gas sample after medication administration
Measured: Pre-medication, 30 minutes post medication, 4 hours post-medication
Improvement in partial pressure of oxygen in the bloodstream
Change in oxygen partial pressure (aka PaO2) as noted on an arterial blood gas sample after medication administration
Measured: Pre-medication, 30 minutes post medication, 4 hours post-medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start20 Apr 2020
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Why it stopped: The investigators never completed the IRB application due to decrease in need to conduct the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will serve as a self-control, with values recorded pre-medication, 30 minutes after medication administration, and 4 hours after administration.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Barbara Cottage Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946162
- Sponsor's protocol ID
- 20-63mrx
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers D, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020 Jul;191:148-150. doi: 10.1016/j.thromres.2020.04.041. Epub 2020 Apr 30.
PubMed 32381264Magro C, Mulvey JJ, Berlin D, Nuovo G, Salvatore S, Harp J, Baxter-Stoltzfus A, Laurence J. Complement associated microvascular injury and thrombosis in the pathogenesis of severe COVID-19 infection: A report of five cases. Transl Res. 2020 Jun;220:1-13. doi: 10.1016/j.trsl.2020.04.007. Epub 2020 Apr 15.
PubMed 32299776Keyaerts E, Vijgen L, Chen L, Maes P, Hedenstierna G, Van Ranst M. Inhibition of SARS-coronavirus infection in vitro by S-nitroso-N-acetylpenicillamine, a nitric oxide donor compound. Int J Infect Dis. 2004 Jul;8(4):223-6. doi: 10.1016/j.ijid.2004.04.012.
PubMed 15234326Akerstrom S, Mousavi-Jazi M, Klingstrom J, Leijon M, Lundkvist A, Mirazimi A. Nitric oxide inhibits the replication cycle of severe acute respiratory syndrome coronavirus. J Virol. 2005 Feb;79(3):1966-9. doi: 10.1128/JVI.79.3.1966-1969.2005.
PubMed 15650225Galie N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26.
PubMed 19470885
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Tadalafil in Confirmed COVID-19 Pneumonia.
- ClinicalTrials.gov ID
- NCT04946162
- Acronym / sponsor ID
- 20-63mrx
- Conditions
- COVID, Sars-CoV2, ARDS, Human
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigators never completed the IRB application due to decrease in need to conduct the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Santa Barbara Cottage HospitalUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 30 Jun 2021 (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.
Our goal is to assess the effects of Tadalafil in the setting of confirmed COVID-19 pneumonia. In particular we plan to assess its effects on oxygen saturation, P:F ratio, and mixed central venous oxygen
We plan to recruit all hospitalized patients at Santa Barbara Cottage Hospital with a confirmed COVID19 pneumonia (positive PCR + clinical signs/symptoms of lower respiratory disease) who meet the Berlin definition of ARDS and have access to measure a mixed venous oxygen saturation. For the purposes of obtaining mixed central venous oxygen, all participating patients will already have an internal jugular central venous catheter in place for inclusion in this study. Since all patients will be intubated, their Legally Authorized Representative (LAR) will be approached to discuss the study and asked to participate in the study by an ICU physician, either the attending physician or a medical resident.
Informed consent will be obtained from the LAR by an ICU attending physician or resident involved in the study prior to participation. Patients who meet the above eligibility criteria will have baseline levels of mixed central venous oxygen, oxygen saturation, P:F ratio, blood pressure and PaO2 recorded.
Each patient will then receive Tadalafil 40mg once. The above listed parameters will be monitored again 30 minutes after drug administration and 4 hours after drug administration. No other medication or ventilator changes will be made during this time period outside of emergent changes in the setting of patient deterioration. We will continue to analyze the data in the event of emergent ventilator changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will serve as a self-control, with values recorded pre-medication, 30 minutes after medication administration, and 4 hours after administration.
| Arm | Type | Receives |
|---|---|---|
| Tadalafil Group | Experimental | Drug: Tadalafil PillEach patient will be given tadalafil 40 mg one time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized patients at SBCH with confirmed COVID19 pneumonia (PCR + clinical signs/symptoms of lower respiratory disease)
- Patients currently on a ventilator
- Patients who meet the Berlin definition of ARDS
- Patients who have access to measure a mixed venous oxygen saturation (i.e., patients with an internal jugular central venous catheter)
- Patient and/or Legally Authorized Representative is willing/able to provide informed consent
Key exclusion criteria (4 listed)
- As tadalafil is currently a FDA Class B1 medication, indicating that little information is available, pregnant women along with women who are actively breastfeeding will be excluded from this series.
- All patients under 18
- Patients who are routinely taking nitrate medications
- All patients using Tadalafil daily for pulmonary arterial hypertension (Note: patients using Tadalafil intermittently for erectile dysfunction may still participate in the study)
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 |
|---|---|---|
| Tadalafil PillEach patient will be given tadalafil 40 mg one time | Drug | Tadalafil Group |
Primary outcome
Improvement in P:F ratio
Time frame: Pre-medication, 30 minutes post medication, 4 hours post-medication
Change in a patient's P:F ratio after medication administration
Improvement in oxygen saturation
Time frame: Pre-medication, 30 minutes post medication, 4 hours post-medication
Change in oxyhemoglobin as noted on an arterial blood gas sample after medication administration
Improvement in partial pressure of oxygen in the bloodstream
Time frame: Pre-medication, 30 minutes post medication, 4 hours post-medication
Change in oxygen partial pressure (aka PaO2) as noted on an arterial blood gas sample after medication administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Background: PubMed 32381264Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers D, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020 Jul;191:148-150. doi: 10.1016/j.thromres.2020.04.041. Epub 2020 Apr 30.
- Background: PubMed 32299776Magro C, Mulvey JJ, Berlin D, Nuovo G, Salvatore S, Harp J, Baxter-Stoltzfus A, Laurence J. Complement associated microvascular injury and thrombosis in the pathogenesis of severe COVID-19 infection: A report of five cases. Transl Res. 2020 Jun;220:1-13. doi: 10.1016/j.trsl.2020.04.007. Epub 2020 Apr 15.
- Background: PubMed 15234326Keyaerts E, Vijgen L, Chen L, Maes P, Hedenstierna G, Van Ranst M. Inhibition of SARS-coronavirus infection in vitro by S-nitroso-N-acetylpenicillamine, a nitric oxide donor compound. Int J Infect Dis. 2004 Jul;8(4):223-6. doi: 10.1016/j.ijid.2004.04.012.
- Background: PubMed 15650225Akerstrom S, Mousavi-Jazi M, Klingstrom J, Leijon M, Lundkvist A, Mirazimi A. Nitric oxide inhibits the replication cycle of severe acute respiratory syndrome coronavirus. J Virol. 2005 Feb;79(3):1966-9. doi: 10.1128/JVI.79.3.1966-1969.2005.
- Background: PubMed 19470885Galie N, Brundage BH, Ghofrani HA, Oudiz RJ, Simonneau G, Safdar Z, Shapiro S, White RJ, Chan M, Beardsworth A, Frumkin L, Barst RJ; Pulmonary Arterial Hypertension and Response to Tadalafil (PHIRST) Study Group. Tadalafil therapy for pulmonary arterial hypertension. Circulation. 2009 Jun 9;119(22):2894-903. doi: 10.1161/CIRCULATIONAHA.108.839274. Epub 2009 May 26.
- Nu-Med Plus Closely Monitoring Outcomes on Two New Human Clinical Trials Using Inhaled Nitric Oxide in Treatment of COVID-19Link provided by the sponsor.
- A Pilot Study of Sildenafil in COVID-19Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tadalafil Pill in people with COVID and Sars-CoV2, run by Santa Barbara Cottage Hospital.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in P:F ratio (time frame: Pre-medication, 30 minutes post medication, 4 hours post-medication). 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 NCT04946162, which also lists 5 linked publications.
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 2 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.