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A 4-week double-blind, randomized, placebo-controlled, phase II study evaluating the effects of oral pamapimod 150 mg with pioglitazone 10 mg daily on COVID-19 evolution and recovery in non-hospitalized patients infected with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2)
EU CTIS ID: 2022-500244-37-00
What this study is testing
Number of days alive with no score > 1 in each of the symptoms and a maximum of 3 points in the total score, measured from inclusion to day 28
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of symptomatic COVID-19 of less than 5 days’ duration, with at least 1 point in at least 4 items of the symptom evaluation table, and at least 2 points in at least 2 items, OR a minimum total score of 6 points (Table 1)
- Diagnosis of COVID-19 confirmed in the last 48 hours by a positive test for SARS-CoV-2 RNA by RT PCR or a rapid validated antigen test (excluding self-test), in a specimen from the upper respiratory tract, the saliva (antigen test), the lower respiratory tract or an expectorated sputum
- No indication that the patient will be hospitalized in the next 48 hours for COVID-19 related reasons
- Adult male or female patients aged ≥ 18 years
- Females must have a negative pregnancy test or must be post-menopausal
- Able to understand and willing to sign an IRB/IEC approved written informed consent document.
You likely can't join if
- Patients with an indication for hospitalization (e.g. SpO2 <92%)
- Liver enzyme elevation more than 3x above normal in the last 4weeks or at inclusion
- Patients who are detained or committed to an institution by a lawcourt or by legal authorities (subject is vulnerable, such as deprived of freedom)
- Patients participating in another clinical trial with a new investigational drug or investigational non-drug treatment
- Known allergy or intolerance to pamapimod or any other ingredient of the IMP or another P38 inhibitor
- Known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the IMP.
See the full eligibility criteria
- Diagnosis of symptomatic COVID-19 of less than 5 days’ duration, with at least 1 point in at least 4 items of the symptom evaluation table, and at least 2 points in at least 2 items, OR a minimum total score of 6 points (Table 1)
- Diagnosis of COVID-19 confirmed in the last 48 hours by a positive test for SARS-CoV-2 RNA by RT PCR or a rapid validated antigen test (excluding self-test), in a specimen from the upper respiratory tract, the saliva (antigen test), the lower respiratory tract or an expectorated sputum
- No indication that the patient will be hospitalized in the next 48 hours for COVID-19 related reasons
- Adult male or female patients aged ≥ 18 years
- Females must have a negative pregnancy test or must be post-menopausal
- Able to understand and willing to sign an IRB/IEC approved written informed consent document.
- Able to understand and be available for daily phone calls to evaluate symptoms.
- Patients with an indication for hospitalization (e.g. SpO2 <92%)
- Liver enzyme elevation more than 3x above normal in the last 4weeks or at inclusion
- Patients who are detained or committed to an institution by a lawcourt or by legal authorities (subject is vulnerable, such as deprived of freedom)
- Patients participating in another clinical trial with a new investigational drug or investigational non-drug treatment
- Known allergy or intolerance to pamapimod or any other ingredient of the IMP or another P38 inhibitor
- Known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the IMP.
- Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV),with hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
- Any use of CYP450 2C8 inducers (e.g. rifampicin)
- Known or suspected active viral (including HIV, hepatitis B, hepatitisC), bacterial, mycobacterial or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.
- Pregnant or breastfeeding women
- Any uncontrolled concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements as determined at the discretion of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.