Title

Randomised Controlled Trial to compare efficacy of standard of care alone and in combination with homoeopathic treatment of COVID-19

Short Title

Standard treatment with homoeopathy as adjuvant in COVID19

Methodology/Design

Randomised control, single blind, parallel group trial

Study Duration

3 months

Study Centre(s)

St. George’s Hospital, Mumbai, Sir JJ Group Of Hopsitals Mumbai.

Background

No definite treatment is known for COVID19 and at present guidelines only recommend supportive care. A rapid cure can result in decreased period of infectivity and also decrease respiratory morbidity and mortality. Use of Homoeopathy as adjuvant to Standard Treatment has helped faster and better recovery in previous epidemic illnesses. This knowledge may be put to use, and further validated in the treatment COVID-19.

Objectives

Primary

To compare duration required for change in disease status (from COVID positive to negative) in patients receiving adjuvant homoeopathic intervention with those receiving conventional treatment as institutional management protocol (IMP) in COVID-19 patients, categorized into moderate to severe stage of the disease

Secondary

To assess overall symptomatic relief to patients through MYMOP2[i] scale

Patients and Methods 

Patients admitted in J.J.  Hospital, Mumbai. For treatment of COVID19 will be provided Homoeopathy as adjuvant treatment with IMP, after informed consent in one arm, and IMP alone in the other.

Number of Subjects

128 (Sample Size calculation explained in 4.7)

Inclusion Criteria

Age > 18 years

All sexes

Case definitions for inclusion in the study will include moderate and severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVID19 issued by Ministry of Health and Family Welfare, Govt of India on 13 June 2020

  Moderate: Pneumonia with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, Respiratory Rate more or equal to 24 per minute.

Severe:

 Adolescent or adult with clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air.

    Acute Respiratory Distress Syndrome Onset:

   New or worsening respiratory symptoms within one week of known clinical insult.

   Chest imaging (Chest X ray and portable bed side lung ultrasound): bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules. Origin of Pulmonary infiltrates: respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic cause of infiltrates/ oedema if no risk factor present.

                                          Oxygenation impairment in adults:

Mild ARDS: 200 mmHg < PaO2/FiO2 ≤ 300 mmHg (with PEEP or CPAP ≥5 cm H2O)

Moderate ARDS: 100 mmHg < PaO2/FiO2 ≤200 mmHg with PEEP ≥5 cm H2O)

   Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS

 CoV-2 test result pending with a high clinical suspicion as defined by:

Cough of <10d duration

Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air

No alternative explanation for respiratory symptoms

     Scheduled for admission or enrolled within 48h of hospital admission

Exclusion criteria

Pregnant and lactating women, infants and neonates

Not willing to give consent for adjuvant treatment

In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.

Symptoms of acute respiratory tract infection for > 10d before randomisation

Death within 24 Hrs.  of admission

Follow-up period

Every 4 hours, or sooner, as per the case.

Outcomes

Primary:

Time taken to get COVID-19 RT-PCR test negative

Secondary:

Change in Scores of COVID Ordinal Clinical Outcomes Scale at D2, D7, D14, D28 (testing sequence explained in 4.6), in comparison to the control group

Change in MYMOP2 scores, in comparison to the control group

End points

1.    COVID-negative in RTPCR

2.    Patient transferred to ventilator

Study Product, Dose, Route, Regimen

Individualized homoeopathic medicine in appropriate dose, orally, thrice daily; or more frequently in severe cases.

Placebo

Placebo group patients will receive identical placebo (globules moistened with dispensing alcohol) as an add on to standard protocol treatment. Dose repetition will be a in similar pattern to medicine group.

Duration of administration

Maximum 28 days (depending on the patient’s admission duration), or Score consistently 0, for 1 week in Ordinal Scale (COOS)

Statistical Methodology

All primary efficacy analyses will be conducted in the Intention-to-treat (ITT) population; thus, all randomized patients should be included in the primary analysis.

Study Team

a) CCRH:

Mentor: Dr. Anil Khurana, Director General

Principal Investigator (Overall): Dr. Harleen Kaur, S1, CCRH, HQ.

Principal Investigator (Site): Dr. Ramesh Bawaskar, S3, RRI(H), Mumbai.

        b) Rejoice Health Foundation:

    Co-Principal Investigator (overall): Dr. Naval Kumar, Global President, Rejoice Health Foundation

        Co-Investigator (Site): Dr. VedatiPackiam, President, RHF, Maharashtra

        c) J.J. Hospital:

    Co-Investigators: 02 doctors will be identified and intimated soon.