COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62671

Dr Ramesh Ks

Ramesh.Ks@syngeneintl.com

2021-12-10

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Long covid

Inclusion Criteria-Part A: <br/ > 1. Positive result of a molecular RT-qPCR diagnostic test or SARS-CoV-2 RNA result from a clinical specimen deemed clinically associated with the current episode of illness, warranting hospital admission as per investigatorâ??s judgement, or previously hospitalized (central and/or local laboratory COVID-19 test results are accepted from any biological material source) <br/ > 2. Hospitalization for COVID -19 respiratory disease and treated with supplemental oxygen (including MV, ECMO or any other means of oxygen administration) in hospital for at least 1 day <br/ > 3. Written, electronic, or oral informed consent from the patient or Legally Authorized Representative prior to any study procedures in a manner approved by an IRB or Ethics Committee <br/ > 4. Male or female, aged â?¥18 to â?¤80 years of age, inclusively at the time of informed consent <br/ > 5. Able to perform and willing to comply with all study procedures and requirements <br/ > 6. Able to bear weight and ambulate a minimum of 10 m distance (use of inhaled oxygen permitted) <br/ > 7. Randomization day is dependent on type of qualifying respiratory support and date of initial confirmed COVID-19 diagnosis as described in Table 1 <br/ > 8. COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan) with a minimum of two lung lobes involvement <br/ > 9. Shortness of breath â?¥ grade 3 on mBDS dyspnea scale <br/ > 10. Laboratory parameters (CBC, biochemistry) deemed by the investigator as acceptable and/or not clinically significant to enroll the patient <br/ > 11. Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must be abstinent from heterosexual intercourse for 90 days following last dose of study medication or agree to use one of the acceptable, highly effective double contraception: <br/ > a. oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation <br/ > b. oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation <br/ > c. intrauterine device (IUD) <br/ > 12. Male patients must be surgically sterile ( > 30 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, <br/ > bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening until study completion, including the follow-up period and an additional 90 days after the last dose of study medication <br/ > 13. Males will not donate sperm for at least 90 days after the last dose of study medication <br/ > 14. Partners of male patients and female patients will report pregnancy occurring within 90 days from cessation of study medication <br/ > 15. Patients can be on other medication (on and off label), apart from the ones specifically outlined in the Exclusion Criteria to treat COVID-19 respiratory disease that the investigator deems clinically relevant in combination with the study drug <br/ > 16. Patients can concomitantly receive any standard of care as per investigatorsâ?? clinical decision, standard of care may encompass any approved medication, on or off label apart from the ones specifically outlined in the exclusion criteria. Concomitant medication may be other medication(s) apart

Exclusion Criteria-Part A: <br/ > 1. Patients who cannot follow-up with study participation requirements <br/ > 2. Investigator considers patient is inappropriate to enroll in the trial <br/ > 3. Pre-existing chronic respiratory condition(s), obstructive or restrictive, for which the patient is actively taking concomitant medication are excluded. Patients with history of Idiopathic Pulmonary Fibrosis (IPF), lung cancer, pulmonary arterial hypertension, other interstitial lung diseases, severe cardiac insufficiency (grade IV) are excluded irrespective of whether they are actively being medicated for those conditions or not. <br/ > 4. Pre-existing co-morbid conditions preventing outcome assessments, e.g., neurological, medical, orthopedic injury/disability, disease or condition that would prevent ability to transfer and walk for 6 minutes, prior to confirmed COVID-19 diagnosis <br/ > 5. Co-morbid diagnosis of tuberculosis <br/ > 6. Unstable angina or myocardial infarction in the last month prior to screening <br/ > 7. Pre-existing co-morbidity associated with life expectancy less than 1 year <br/ > 8. Present life expectancy less than 3 days and/or LDH > 360 <br/ > 9. Body mass index â?¥ 45kg/m2 <br/ > 10. Resting heart rate of â?¥ 120 bpm, systolic blood pressure of > 180 mm Hg and a diastolic blood pressure of > 100 mm Hg and/or or a fall in pulse oximetry oxygen saturation (SpO2) to <80% upon ambulation <br/ > 11. Sepsis, septic/hypovolemic/cardiogenic/neurogenic shock <br/ > 12. Patients on MV, ECMO, NIV, HFNO or other high flow oxygen (FiO2 â?¥35% and flow rate â?¥ 8 lpm) within the last 72 hours prior to screening <br/ > 13. History of anaphylactic reaction (particularly reactions to general anesthetic agents), allergic reaction due to any drug which led to significant morbidity, prior allergic reaction to pirfenidone. <br/ > 14. Known symptoms of dysphagia or known difficulty in swallowing capsules and/or total gastrectomy <br/ > 15. Patients undergoing dialysis or hemoperfusion, or with a history of dialysis or hemoperfusion, or anticipated to require dialysis or hemoperfusion within 72 hours of screening or severe renal impairment (defined as creatinine clearance rate <30 mL/min) at the time of screening/baseline. <br/ > 16. Use of any of the following drugs: <br/ > a. Fluvoxamine, enoxacin, ciprofloxacin <br/ > b. Treatment with steroids under institutional protocols and guidelines to manage COVID-19 pneumonia/respiratory symptoms is allowed. Use of steroids off-label to treat non-COVID-19 related conditions is not allowed. <br/ > c. Any Investigational Agents (i.e., non-approved or nonauthorized drugs), with the exception of those used for COVID-19 respiratory diseases that the investigator deems clinically relevant in combination with the study drug, as described below: <br/ > i. Allowed agents <br/ > â?¢ Patients who had received prior investigational agents for COVID-19 but are no longer taking those drugs are allowed. <br/ > â?¢ Inhaled corticosteroids are allowed. <br/ > â?¢ Patients that received prior convalescent plasma are allowed, however, concomitant convalescent plasma is excluded. <br/ > ii. Excluded agents <br/ > â?¢ Patients on concomitant experimental anti-viral, anti-fibrotic or anti-inflammatory therapies are excluded. <br/ > â?¢ Any investigational agent not explicitly on this list should be reviewed by the medical monitor prior to initiating therapy or enrolling participant. <b

2

PureTech

18

80

Argentina;Brazil;India;Philippines;Republic of Moldova;Romania;Ukraine;United Kingdom;United States

Patients recovered from covid

N/A

168

To evaluate the effect of LYT-100 on the change in distance walked on six-minute walk test (6MWT) performed as per the American Thoracic Society/European Respiratory Society Guidelines (Crapo et al 2002).Timepoint: All patients will be treated up to 91 consecutive days during the study treatment period. Study assessments are at Days 14; 28; 56 and Day 91 ± 3 days.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2

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