Trial NCT04489446
Publication Santamarina MG, SSRN, 2021 (preprint)
Dates: 2020-08-20 to 2021-03-31
Funding: No specific funding (No external sources of funding)
Conflict of interest: No
| Methods | |
| RCT Blinding: triple blinding | |
| Location :
Single center / Chile Follow-up duration (days): * | |
| Inclusion criteria | Adult patients (>18 years of age) with a RT-PCR confirmed SARS-COV-2 infection or patients with high clinical suspicion of a SARS-COV-2 infection; admitted for inpatient treatment at Hospital Naval Almirante Nef and showing perfusion abnormalities in a sCTA carried out during the first 24 hours of admission |
| Exclusion criteria | Nitrate users; patients with a recent diagnosis of coronary heart disease (less than 6 months); decompensated heart failure, recent ischemic stroke (less than 6 months), global respiratory failure with hypercapnia, sildenafil allergy, chronic liver disease (Child-Pugh B or C), chronic kidney disease (stage IV or V), pulmonary hypertension, and users of p450 cytochrome inhibitors |
| Interventions | |
| Treatment
Sildenafil 25 mg orally three times per day for 7 days |
|
| Control
Placebo | |
| Participants | |
| Randomized 40 participants (n1=20 / n2= 20) | |
| Characteristics of participants N=40 Mean age : 55.8 33 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=0 | |
| Primary outcome | |
| In the register Arterial Oxygenation [ Time Frame: One hour after sildenafil administration ]; Arterial Oxygenation [ Time Frame: Daily until the end of follow-up (up to 15 days after randomisation) ]; Alveolo-arterial gradient [ Time Frame: One hour after sildenafil administration ]; Alveolo-arterial gradient [ Time Frame: Daily until the end of follow-up (up to 15 days after randomisation) ] | |
| In the report Change in oxygenation, quantified using the ratio between arterial oxygen partial pressure and fractional inspired oxygen (PaO2/FiO2 ratio). Alveolar-arterial oxygen gradient was a co-primary endpoint. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
* |
| General comment | In addition to the preprint article, the study registry was available for data extraction. The study achieved the target sample size specified in the trial registry. There were no changes from the trial registration in the intervention and control treatments. There were no review specific outcomes reported or extracted. |