An Open Label, Multicentre, Multi-Dose, Single Arm Treatment Clinical Trial in Human Adult, Patients With Mild COVID-19.
- Conditions
- Either in fasting or fed condition
- Registration Number
- CTRI/2021/05/033846
- Lead Sponsor
- Martin Sinclair BB Corp
- Brief Summary
**Study Title**
An Open Label, Multicentre, Multi-Dose, Single Arm Treatment Clinical Trial To Determine The Safety And Efficacy of Earth Tea Manufactured By Martin Sinclair B4B Corp,40, Remsen Ave, Brooklyn, NY 11212 ,United States in Human Adult, Patients with Mild COVID-19. **Treatment 01:** The product is a Earth Tea Manufactured By Martin Sinclair B4B Corp, 40, Remsen Ave, Brooklyn, NY 11212,United States.
**Primary Objective:**
To Determine The Safety And Efficacy of Earth Tea Manufactured By Martin Sinclair B4B Corp,40, Remsen Ave, Brooklyn, NY 11212 ,United States in Human Adult, Patients with Mild COVID-19.
**Secondary objective:**
To monitor the safety and tolerability of a multi-dose administered in Human Adult, Patients With COVID-19 Infections.
**Study design:**
An Open Label, Multicentre, Multi-Dose, Single Arm Treatment Clinical Trial in Human Adult, Patients With Mild COVID-19.
**Study Population**
15 Patients with Mild COVID- 19 will be receiving Earth Tea.
**Primary Enrolment criteria**
Demographic data, medical and medication history, physical examination, and RT-PCR will be collected prior to study enrolment. Documentation of CT-Chest if available will be collected prior to study enrolment.
Note: During patient screening if there is any documentary diagnosis missing in few parameters, same should be done before enrollment of study. Aside from a diagnosis of Covid-19, no other medical issues should be found in these patients.
**Study Duration**
The study duration is 03 days for each patient.
***Inclusion criteria:***
Patients meeting all of the following criteria will be considered for enrollment in the study:
1. Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
2. Age 18-75 years (both inclusive) at the time of signing ICF.
3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization).
4. Patients with uncomplicated respiratory tract viral infection
5. For female patients: evidence of post-menopause or for Pre-menopause patients, negative pretreatment serum or urine pregnancy test.
6. Eligible patients of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.
7. Not participating in any other interventional drug clinical studies before completion of the present study
8. Controlled diabetic patients with HbA1C limit< 7.0
9. Hypertension Patients up till Hypertension Stage 2 shall be included in the study (Systolic blood pressure at least 140mm Hg and Diastolic blood pressure at least 90 mm Hg)
10. Time interval between symptoms onset and randomization to no more than 7 days.
11. Pyrexia (axillary > 98.6°F or frontal >99.5°F); or/and any of the following symptoms:
· Cough
· Sore throat
· Headache
· Nasal congestion
· Body aches and pains
· Fatigue
12. Patients with Loss of smell and Taste.
**Exclusion criteria:**
COVID - 19 patients with history or significant presence of the following will be excluded from participation/enrollment in the study trial:
1. Severe infection, defined as oxygen saturation (SPO2) ≤93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) ≤300 mmH or need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support.
2. Requires ICU care for management of ongoing clinical status.
3. Participation in this study will not be in the best interest of the patient, or any other circumstances that prevent the patient from participating in the study safely.
4. Inability to intake or tolerate oral medications like refractory nausea, vomiting, or gastrointestinal disorders, or having undergone extensive bowel resection which may affect adequate absorption of the drug.
5. Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis; CrCl is to be calculated by the following Cockcroft-Gault formula only when the serum creatinine is >1.5×ULN.
6. patient has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary (Asthma, chronic obstructive lung disease), neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
7. Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year).
8. Known severely reduced LV function (Ejection fraction<30%)
9. Severe liver disease: underlying liver cirrhosis or Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN.
10. Gout/history of gout or hyperuricemia (above the ULN).
11. Pregnant or lactating women.
12. Having participated in any other interventional drug clinical study within 30 days prior to first dose of study drug.
13. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission.
14. Patients with diabetes having HbA1C limit> 7.0
15. Patients with Hypertensive crisis.
**Dose and method of administration**
**Treatment Arm 01:** In the morning 08 Oz of cold tea will be administered orally, (shake well before administration ) and 08 Oz of Hot tea will be administered hot after 12 hours exactly two hours before Bed.
**Note:** If the symptoms worsen the patient can be given Standard Treatment at the discretion of Site Investigator.Preliminary procedures including signing the ICF will be done before initiating the treatment.
- Study enrolment visit (Day 00)
- On Therapy visit (Day 01)
- Evaluation visit (Day 02)
**Efficacy analysis:**
· Clinical cure and Microbiological cure efficacy analysis on Day 02( End of Study)
· Microbiological cure efficacy analysis on Day 02
**Note:**
· Clinical cure has to be maintained up to 48 hours
- Patients respond or not to treatment, based on the efficacy evaluation on the Day 02 for clinical cure and microbiological cure.
After Day 02 Patient can be continued with Standard Treatment based on the discretion of Investigator.
**Patient Safety Measure**
On every Visit, Vital signs like Pulse, Body temperature, Saturation (SpO2) level, Blood Pressure, Respiratory Rate will be measured.
**Primary End Point:**
· Proportion of patients with Microbiological cure at Day 02.
o Microbiological cure defined as negativity in SARS-CoV2 RT-PCR.
· Proportion of Patients with Clinical cure at Day 02.
o Clinical Cure defined as
§ Continuous decrease in temperature or attaining normal temperature (normal temperature rate axillary> 97.8°F)
§ Mild or no cough
Note: Clinical cure has to be maintained for at least 48 hours.
· Proportion of Patients with restoration of Taste at Day 02.
· Proportion of Patients with restoration of Smell at Day 02.
**Statistical Procedure**
The statistical evaluation will be performed using Chi square test.Statistical analysis will be performed using the latest version of SAS®system software (SAS Institute Inc., USA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
- 1.Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
- 2.Age 18-75 years (both inclusive) at the time of signing ICF.
- 3.Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization).
- 4.Patients with uncomplicated respiratory tract viral infection 5.For female patients: evidence of post-menopause or for Pre-menopause patients, negative pretreatment serum or urine pregnancy test.
- 6.Eligible patients of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.
- 7.Not participating in any other interventional drug clinical studies before completion of the present study 8.Controlled diabetic patients with HbA1C limit< 7.0 9.Hypertension Patients up till Hypertension Stage 2 shall be included in the study (Systolic blood pressure at least 140mm Hg and Diastolic blood pressure at least 90 mm Hg) 10.Time interval between symptoms onset and randomization to no more than 7 days.
- 11.Pyrexia (axillary > 98.6°F or frontal >99.5°F); or/and any of the following symptoms: •Cough •Sore throat •Headache •Nasal congestion •Body aches and pains •Fatigue 12.Patients with Loss of smell and Taste.
19 patients with history or significant presence of the following will be excluded from participation/enrollment in the study trial: 1.Severe infection, defined as oxygen saturation (SPO2) ≤93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) ≤300 mmH or need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. 2.Requires ICU care for management of ongoing clinical status. 3.Participation in this study will not be in the best interest of the patient, or any other circumstances that prevent the patient from participating in the study safely. 4.Inability to intake or tolerate oral medications like refractory nausea, vomiting, or gastrointestinal disorders, or having undergone extensive bowel resection which may affect adequate absorption of the drug. 5.Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis; CrCl is to be calculated by the following Cockcroft-Gault formula only when the serum creatinine is >1.5×ULN. 6.patient has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary (Asthma, chronic obstructive lung disease), neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. 7.Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). 8.Known severely reduced LV function (Ejection fraction<30%) 9. Severe liver disease: underlying liver cirrhosis or Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN. 10. Gout/history of gout or hyperuricemia (above the ULN). 11. Pregnant or lactating women. 12. Having participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. 13. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission. 14.Patients with diabetes having HbA1C limit> 7.0 15. Patients with Hypertensive crisis.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with Microbiological cure at Day 02. Study enrolment visit (Day 00) | On Therapy visit (Day 01) | Evaluation visit (Day 02)
- Secondary Outcome Measures
Name Time Method Frequency of treatment-emergent adverse event at Day 02. Study enrolment visit (Day 00)
Trial Locations
- Locations (1)
KMS Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
KMS Hospital🇮🇳Kancheepuram, TAMIL NADU, IndiaDr Reenee RajanPrincipal investigator09597160715reenee@microtheraps.comSubhashiniPrincipal investigator09940502533subhashini.r@microtheraps.com