SP16 as a Therapeutic for COVID-19 Induced ARDS (NCT05135624) | Clinical Trial Compass
TerminatedPhase 1
SP16 as a Therapeutic for COVID-19 Induced ARDS
Stopped: Trial was terminated due to lack of patients.
United States2 participantsStarted 2021-12-01
Plain-language summary
This randomized, double-blind, placebo-controlled, Phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of SP16, an anti-inflammatory drug, in patients with pneumonia due to SARS-CoV-2 infection. The study will enroll up to 20 patients and each eligible patient will be randomized to receive either one of two doses of SP16 (6 mg or 12 mg) or placebo by subcutaneous injection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
To be considered eligible to participate in this study, the subject must meet all of the Inclusion criteria listed below:
* Hospitalized patients age ≥ 18 with diagnosis of SARS-CoV-2-infection based on positive
* PCR test result and can provide informed consent
* Diagnosed with pneumonia due to SARS-CoV-2
* Respiratory rate ≥ 25/minute and SpO2 ≤ 93%
* Review of Chest radiograph, chest computed tomography (CT) scan, or chest ultrasound consistent with bilateral infiltrates.
* Horowitz index (partial pressure of oxygen/fraction of inspired oxygen \[PaO2/FiO2\]) ≤ 300. If a subject does not have an arterial line in place, a SpO2/FiO2 ≤ 315 may be used.
Exclusion Criteria:
To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
* Age \< 18
* Pregnant or lactating women
* History of heart failure
* Clinically significant cardiac dysrhythmia, as determined by investigator
* History renal impairment
* Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2