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Cysteamine in association with standard therapy for the treatment of hospitalized patients with COVID-19 pneumonia: phase 2 study on safety of a new antiviral and direct therapy on the host
EU CTIS ID: 2024-516800-40-00
What this study is testing
Safety of cysteamine in hospitalized patients with COVID-19 pneumonia not requiring high oxygen flows, whether or not previously vaccinated with anti-COVID-19 vaccines.
- 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
- Age ≥18 years
- Infertility condition (postmenopausal, surgically induced infertility e.g., vasectomy with documented azoospermia for men or tubal closure for women) or in potentially fertile subjects, negative urinary pregnancy test (women), and consent to adhere to the following contraception requirements from 2 weeks prior to enrollment to 18 weeks after experimental drug administration (men and women)
- Positive nasopharyngeal swab for SARS-CoV-2 (antigenic or molecular test)
- Onset of COVID-19 symptoms related ≤10 days
- Clinical signs and symptoms of COVID-19 pneumonia
- Imaging examination (X-ray/echo/TAC) of the chest compatible with COVID-19 pneumonia not requiring high oxygen flows
You likely can't join if
- Age <18 years
- Seropositivity for HIV, HCV, HBV (HBsAg positivity)
- Liver failure (Child A-C), renal failure (creatinine clearance < 50 ml/min), heart failure (NYHA IV), active stage neoplasms (those who have had cycles of chemotherapy including biologic drugs and/or radiation therapy in the past 6 months), ongoing neurological/psychiatric pathology (e.g., depression, psychotic crisis, suicide attempt)
- Gastric/duodenal ulcer undergoing treatment
- Systemic lupus erythematosus (autoimmune disease)
- Hypersensitivity to cysteamine or penicillin
See the full eligibility criteria
- Age ≥18 years
- Infertility condition (postmenopausal, surgically induced infertility e.g., vasectomy with documented azoospermia for men or tubal closure for women) or in potentially fertile subjects, negative urinary pregnancy test (women), and consent to adhere to the following contraception requirements from 2 weeks prior to enrollment to 18 weeks after experimental drug administration (men and women)
- Positive nasopharyngeal swab for SARS-CoV-2 (antigenic or molecular test)
- Onset of COVID-19 symptoms related ≤10 days
- Clinical signs and symptoms of COVID-19 pneumonia
- Imaging examination (X-ray/echo/TAC) of the chest compatible with COVID-19 pneumonia not requiring high oxygen flows
- Low-flow respiratory support with Venturi mask or goggles with a pO2/FiO2 ratio (index derived from the ratio of PaO2 detected by blood gas analysis, to the fraction of oxygen, FiO2 administered) > 200mmHg
- Body Weight ≥50 kg
- Ability to provide informed consent
- Ability to adhere to follow-up visits
- Age <18 years
- Seropositivity for HIV, HCV, HBV (HBsAg positivity)
- Liver failure (Child A-C), renal failure (creatinine clearance < 50 ml/min), heart failure (NYHA IV), active stage neoplasms (those who have had cycles of chemotherapy including biologic drugs and/or radiation therapy in the past 6 months), ongoing neurological/psychiatric pathology (e.g., depression, psychotic crisis, suicide attempt)
- Gastric/duodenal ulcer undergoing treatment
- Systemic lupus erythematosus (autoimmune disease)
- Hypersensitivity to cysteamine or penicillin
- Drug/alcohol abuse
- Inability to understand and sign informed consent
- Presence of any physical or psychological condition that, in the opinion of the principal investigator, makes participation in the study not recommended
- pO2/FiO2 ratio ≤ 200 mmHg
- Need for oxygen at high flows (CPAP/NIV/VM/ECMO)
- Use of antiretroviral drugs
- Hemoglobin concentration less than 10 g/dl
- Elevation of creatinine kinase at baseline more than three times the upper limit of normal
- Abnormal laboratory values at baseline (baseline alanine aminotransferase (ALT) concentration more than three times the upper limit of normal, serum creatinine concentration more than twice the upper limit of normal, serum total bilirubin level more than twice the upper limit of normal, platelet count <100,000/mm3, white blood cell (WBC) <2500 (mcL)
- Pregnancy or breastfeeding
- Silico-tuberculosis
The study team makes the final eligibility decision.
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.
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.