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CTRI Number  CTRI/2021/05/033846 [Registered on: 28/05/2021] Trial Registered Prospectively
Last Modified On: 05/08/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   An Open Label, Multicentre, Multi-Dose, Single Arm Treatment Clinical Trial in Human Adult, Patients With Mild COVID-19. 
Scientific Title of Study   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. 
Trial Acronym  EART-001-21 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reenee Rajan 
Designation  Principal Investigator 
Affiliation  KMS Hospital 
Address  Door No.6, Kamarajar Salai, Ground Floor, Room No. 1 Clinical department
Selaiyur, East Tambaram
Kancheepuram
TAMIL NADU
600059
India 
Phone  919940502533  
Fax    
Email  reenee@microtheraps.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reenee Rajan 
Designation  Principal Investigator 
Affiliation  KMS Hospital 
Address  Door No.6, Kamarajar Salai, Clinical department, Room No.1, Ground Floor
Selaiyur, East Tambaram
Kancheepuram
TAMIL NADU
600059
India 
Phone  919940502533  
Fax    
Email  reenee@microtheraps.com  
 
Details of Contact Person
Public Query  
Name  Dr Reenee Rajan 
Designation  Principal Investigator 
Affiliation  KMS Hospital 
Address  Door No.6, Kamarajar Salai, Clinical department, Room No.1, Ground Floor
Selaiyur, East Tambaram
Kancheepuram
TAMIL NADU
600059
India 
Phone  919940502533  
Fax    
Email  reenee@microtheraps.com  
 
Source of Monetary or Material Support  
Martin Sinclair BB Corp 40 Remsen Avenue, Brooklyn Ny 11203 USA 
 
Primary Sponsor  
Name  Martin Sinclair BB Corp 
Address  USA 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reenee Rajan  KMS Hospital  Door No.6, Kamarajar Salai, Selaiyur, East Tambaram, 600059
Kancheepuram
TAMIL NADU 		 09597160715

reenee@microtheraps.com 
Subhashini  KMS Hospital  Plot no.46, Rengasamy street, Chrompet
Kancheepuram
TAMIL NADU 		 09940502533

subhashini.r@microtheraps.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Hycare Super Specialty Ethics Committee  Approved 
SRI DURGAMBA INDEPENDENT ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Either in fasting or fed condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Frequency of treatment-emergent adverse event at Day 02.   Study enrolment visit (Day 00)
On Therapy visit (Day 01)
Evaluation visit (Day 02)
 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/06/2021 
Date of Study Completion (India) 14/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/07/2021 
Estimated Duration of Trial   Years="0"
Months="0"
Days="3" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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).
 
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