A Randomized Double Blind Controlled study to assess the dose related effect of Mycobacterium w on clinical course of Corona Virus Disease 2019 (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.To compare the symptoms relief over the time among the three treatment group.
研究概览
简要总结
The study is a three arm, double blind, placebo controlled, clinical trial to assess the dose related effect of heat killed Mycobacterium w versus Placebo administered along with Standard care in Patients of COVID-19.
Time bound study for one year of duration.
Written and informed consent shall be taken from the patient prior to study. This is a randomized, double blind, three arm, time bound study for 1 year wherein laboratory confirmed symptomatic COVID-19 patients admitted in COVID-19 isolation ward at SGT Hospital shall be included after the inclusion and exclusion criteria have been applied. The patients will be randomly divided into 3 groups. Selection of patients in either group will be random as per randomization list and accordingly patient will be enrolled in either of the study group to receive study medication (either Mw or placebo) as per randomization list. Patients in control group would be administered placebo in a dose of 0.3 ml intradermally daily for 3 consecutive days at 3 different sites. The test group would be further divided into 2 groups. Patients in Group A shall be administered 0.3ml daily of Sepsivac intradermally in divided doses of 0.1 ml each for 3 consecutive days at 3 different sites. Patients in Group B would be administered 0.3 ml of Sepsivac intradermally in divided doses of 0.1 ml at three different sites for 1 day and placebo 0.3 ml intra dermally daily for next two consecutive days. A smaller gauge needle (26 G) would be used.
Study duration for each patient would be till the time of discharge from hospital or till day 28 from the first dose administration. Study medication will be administered for three consecutive days along with standard of care. The standard of care therapy for COVID-19 would be given to every patient as per hospital practice.
During hospitalization, daily clinical evaluation and assessment of patient will be done as per study calendar and recorded in the proforma till the time of discharge from hospital.
| Study Group |
Treatment Allocation
|Treatment Group 1
Heat killed Mycobacterium w suspension group:
0.3 ml of Mw daily (0.1 ml x3injections) intradermally at 3 different sites for 3 consecutive days along with standard therapy of COVID-19.
|Treatment Group 2
Heat killed Mycobacterium w suspension + placebo group:
0.3 ml of Mw (0.1 ml x 3 injections) intradermally at 3 different sites for 1 day followed by 0.3 ml (0.1 ml x 3 injections) of placebointradermally at 3 different sites for next 2 consecutive days along with standard therapy of COVID-19.
|Treatment Group 3
Placebo group:
0.3 ml daily (0.1 ml x 3 injections) of placebo intradermally at 3 different sites for 3 consecutive days along with standard therapy of COVID-19.
STUDY CALENDER
| Procedure |
Baseline$
Day 1$
Day 2
Day 3
Day 4
Day 7
Day 14
Day 21
End of study@
|Informed consent
X
|Inclusion and Exclusion criteria
X
|Demographics
X
|Medical history
X
|Pregnancy test , (if applicable)
X
|Physical Examination#
X
X
X
X
X
X
X
X
X
|Temperature#
X
X
X
X
X
X
X
X
X
|Vital signs#
X
X
X
X
X
X
X
X
X
|SpO2#
X
X
X
X
X
X
X
X
X
|Oxygen requirement#
X
X
X
X
X
X
X
X
X
|Ordinal Scale evaluation#
X
X
X
X
X
X
X
X
X
|Medications administered#
X
X
X
X
X
X
X
X
X
|Study medication administration
X
X
X
|Development of new symptoms#
X
X
X
X
X
X
X
X
|Nasal or oropharyngeal swab*
X
X
X
X
X
X
|Assessment of leucocyte count*
X
X
X
X
X
X
|Assessment of SARS-Cov-02 specific IgG / IgMlevel
X
$Screening activities can be conducted either at baseline or during day 1 visit prior to dosing (same day screening).
#Activities to be performed daily during hospitalization till recovery.
@End of study (Upto Day 28 or till recovery [discharge from hospital]
*Will be performed during base line / screening and on Day 4, subsequently it will be performed as per hospital’s standard procedure.
If any other investigation performed, will be documented.
If patient is discharged from hospital earlier than 28 days, the activities of End of Study will be performed as per calendar on the day of discharge and in case patient is transfer to HDU/ICU during the course of study earlier than 28 days, the efficacy analysis and activities of End of study and safety follow up will continue till day 28 post-1st dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Laboratory confirmed symptomatic COVID-19 patients with ordinal scale of 3&
- •2.Female patients who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing.
- •3.The patients must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.
排除标准
- •1.Patient with ordinal scale of ≥5 at the time of hospital admission and randomization.
- •2.Pregnant and / or lactating female patients.
- •3.A family history of congenital or hereditary immunodeficiency.
- •4.Any disease condition requiring ICU admission or which in the judgment of the Investigator would compromise the patient’s health.
- •5.History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator.
- •6.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period.
- •7.History of allergic reactions or anaphylaxis to Mycobacterium w or its component.
- •8.Patients with generalized septic skin conditions.
- •9.Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patient’s health or is likely to result in nonconformance to the protocol or a patient’s ability to give written informed consent.
结局指标
主要结局
1.To compare the symptoms relief over the time among the three treatment group.
时间窗: 1. Daily assessment of the patient. | 2. At the end of 28 days or discharge of the patient- whichever is earlier.
2.To compare the difference in proportion of patients with improved clinical outcome defined by ordinal scale over the time between the treatment groups.
时间窗: 1. Daily assessment of the patient. | 2. At the end of 28 days or discharge of the patient- whichever is earlier.
3.To compare the duration for conversion of Covid-19 positive status to negative between the treatment groups.
时间窗: 1. Daily assessment of the patient. | 2. At the end of 28 days or discharge of the patient- whichever is earlier.
次要结局
- 1.To compare the incidence of adverse events and serious adverse events between the three arms till the end of study.(2.To compare the proportion of patients discharged from hospital or transfer to HDU/ICU over the time between the three arms.)