SPI-1005 Treatment in Severe COVID-19 Patients (NCT04483973) | Clinical Trial Compass
CompletedPhase 2
SPI-1005 Treatment in Severe COVID-19 Patients
United States25 participantsStarted 2021-08-27
Plain-language summary
The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.
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:
* Adults ≥18 years of age
* Positive nCoV2 PCR test by nasopharyngeal, oral, saliva, or respiratory sample
* Clinical signs, symptoms, and respiratory status consistent with severe COVID-19
* Score of 5-7 on the WHO Ordinal Scale
* Onset of severe COVID-19 symptoms ≤7 days of study enrollment
* Subject is in-patient at time of randomization to study treatment
* Subject or legally authorized representative is willing and able to provide informed consent, and agrees for subject to comply with planned study procedures including reproductive requirements
Exclusion Criteria:
* Female patients who are pregnant or breastfeeding.
* Participation in another interventional investigational drug or device study concurrently or within 30 days prior to study consent.
* Patients with impaired hepatic or renal function.
* Subject has any other illness or condition that, in the opinion of the investigator, would prohibit the subject from participating.
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
Number of Participants With Treatment-related Adverse Events