CTRI/2021/06/034404
Completed
Phase 2
A Phase 2 evaluation of the safety and efficacy of homoeopathic remedy EpiphaniQ in adult patients with mild to moderate COVID-19: Randomized, open label, controlled, multicenter trial
EpiphaniQ LLP0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: B342- Coronavirus infection, unspecified
- Sponsor
- EpiphaniQ LLP
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Hospitalized patient with laboratory\-confirmed SARS\-CoV\-2 infection as determined by polymerase chain reaction (PCR) or Rapid Antigen Test as documented by either of the following: PCR positive in sample collected \< 72 hours prior to randomization; OR PCR positive in sample collected \= 72 hours prior to randomization with documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking \>24 hours, etc.)
- •2\. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures.
- •3\. Male or non\-pregnant female adult \=18 years of age at time of enrolment.
- •4\. For mild cases subjects without evidence of breathlessness or Hypoxia (normal saturation)
- •5\. For moderate cases Illness with \=12 days duration, and at least one of the following: i. Radiographic infiltrates by imaging captured during the period between date of admission to date of enrolment (chest x\-ray, CT scan, lung ultrasound, and etc.), OR ii. Presence of clinical features of dyspnea and or hypoxia, fever cough including Respiratory rate \> 24 breaths/min OR SpO2 90 to \= 93% on room air, OR iii. Requiring supplemental oxygen.
- •6\. Women of childbearing potential must agree either to abstinence or to use at least one primary form of contraception not including hormonal contraception from the time of screening till end of the study.
- •7\. Subject (or legally acceptable representative) agrees to not participate in another clinical trial for the treatment of COVID\-19 or SARS\-CoV\-2 till end of this study.
- •8\. Subject (or legally acceptable representative) is willing to be a study participant and to accept randomization to any assigned treatment arm.
Exclusion Criteria
- •A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
- •1\. Physician makes a decision that trial involvement is not in patient’s best interest, or there is any condition that does not allow the protocol to be followed safely.
- •2\. Patient already in, or has already been in, another clinical trial of an experimental treatment for COVID\-19
- •3\. Patient has a PaO2/FiO2 ratio \< 200 or is requiring IMV/ECMO at baseline.
- •4\. Known medical history of allergy to Zn
- •5\. Severe hepatic impairment defined as Child C liver disease.
- •6\. eGFR \= 30 mL/min/1\.73 m2 (defined using CKD\-EPI SCr formula)
- •7\. History of any organ transplant which requires active immunosuppressive treatment which can interfere with kidney function
- •8\. If a patient required cardiopulmonary resuscitation (CPR) within 14 days
- •9\. Already receiving dialysis (either acute or chronic) or imminent need of dialysis at the time of enrolment
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 2
A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy with duodenojejunal bypass for obesity with diabetes mellitusMorbid obesity with diabetes mellitusJPRN-UMIN000035537Kansai Medical University Hospital33
Recruiting
Not Applicable
A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus (Advanced medical care A)Morbid obese patients with diabetes mellitusJPRN-UMIN000030837Tohoku University Hospital10
Recruiting
Not Applicable
A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitusMorbid obese patients with diabetes mellitusJPRN-UMIN000016208Tohoku University Hospital10
Active, not recruiting
Phase 1
A phase II study assessing safety and efficacy of Cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failureRecurrent unresectable or metastatic cervix carcinomaMedDRA version: 21.1Level: PTClassification code 10008344Term: Cervix carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-002184-97-FRCentre François Baclesse57
Active, not recruiting
Phase 1
Evaluation of the safety and efficacy of the drug AL8326 in the post-first treatment of small cell lung cancer.Small Cell Lung Cancer (SCLC) patients who need =2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage., Small Cell Lung Cancer (SCLC) patients who need =2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.MedDRA version: 21.1Level: PTClassification code: 10041067Term: Small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]CTIS2023-509067-24-00Advenchen Pharmaceuticals LLC130