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1.
Journal of Cardiovascular Disease Research ; 13(8):2108-2118, 2022.
Article in English | GIM | ID: covidwho-2271402

ABSTRACT

Since the COVID-19 pandemic, the world began a frantic search for possible prophylactic options. We conducted a study to assess the role of hydroxychloroquine for COVID-19 prophylaxis in health-care workers. The study was a prospective cohort with four arms (high, medium, low dose, and control) of HCQ prophylaxis. Participants were grouped as per their opting for any one arm on a voluntary basis as per institute policy. The outcomes studied were COVID-19 positivity by RT-PCR and its severity assessed by WHO COVID-19 severity scale. Total 486 participants were enrolled, of which 29 (6%) opted for low dose, 2 (<1%) medium dose, and none for high dose HCQ while 455 (93.6%) were in the control arm. Of the 164 participants who underwent RT-PCR, 96 (58.2%) tested positive. Out of these 96 positive cases, 79 [82.3%] were ambulatory and were managed conservatively at home. Only 17.7% participants, all from the control group, required hospitalization with the mild-moderate disease. None of the participants had severe disease, COVID-related complications, ICU stay, or death. The difference in the outcome was statistically insignificant (p value >0.05). This single-centre study demonstrated that HCQ prophylaxis in healthcare workers does not cause a significant reduction in COVID-19 as well as mitigating its severity in those infected. At present, most of the trials have not shown any benefit. Though COVID-19 vaccines have reduced the need for prophylaxis, the search for a safe and reasonable chemoprophylaxis should continue until a large population of individuals gets vaccinated, especially in underdeveloped countries.

2.
CTRI; 23-12-2020; TrialID: CTRI/2020/12/029981
Clinical Trial Register | ICTRP | ID: ictrp-CTRI202012029981

ABSTRACT

Condition:

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B338- Other specified viral diseases

Primary outcome:

Incidence of acute myocardial events in COVID-19 population at baseline

and during hospital stayTimepoint: Incidence of acute myocardial events in COVID-19 population at baseline

and during hospital stay

Criteria:

Inclusion criteria: Patients with COVID 19 disease confirmed by RTPCR

Age greater than 18 years

Exclusion criteria: Not giving informed consent

3.
medrxiv; 2020.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2020.11.23.20232116

ABSTRACT

BACKGROUND & AIMS The use of hydroxycholoroquin for COVID 19 treatment and prophylaxis raised issues concerning its cardiac safety owing to possibility of QT prolongation and arrhythmias. 1 There was no study on long term electrocardiographic telemetry monitoring of patients taking hydroxychloroquin and we planned a continuous electrocardiographic holter telemetry of these patients for a period of seven days. Methods Healthcare workers taking hydroxycholoroquin as pre exposure prophylaxis, patients taking hydroxychloroquin were monitored by holter electrocardiographic telemetry with continuous beat to beat analysis for seven days with capacity to report any arrhythmic event or significant QT prolongation instantly to medical faculty. Results 25 participants with mean age 42.4 ± 14.1 years, 40% females. 20% patients needed to stop HCQ. Four patients developed QT prolongation > 500 ms and needed to stop HCQ, one patient had accelerated idioventricular rhythm and stopped treatment. one had short episodes of atrial fibrillation. No malignant arrhythmia or ventricular arrhythmia or torsades were noted. No episode of significant conduction disturbance and arrhythmic death noted. Baseline mean QTc was 423.96 ± 32.18 ms, mean QTc corrected at 24 hours 438.93 ± 37.95, mean QTc 451.879 ± 37.99 at 48 hours, change in baseline mean QTc to max QTc was 30.74 ± 21.75 ms at 48 hours. All those develop QTc prolongation > 500 ms were greater than 50 years of age. Conclusion Ambulatory telemetry ECG monitoring seems to detect early QT prolongation and stopping drug timely prevented malignant arrhythmias. HCQ seems to have less risk of QT prolongation in young healthy individuals.


Subject(s)
Accelerated Idioventricular Rhythm , Arrhythmias, Cardiac , Death , Atrial Fibrillation
4.
CTRI; 27-07-2020; TrialID: CTRI/2020/07/026820
Clinical Trial Register | ICTRP | ID: ictrp-CTRI202007026820

ABSTRACT

Intervention:

Intervention1: Curcumin: Oral Curcumin capsule 500 mg twice daily (morning , evening ) for 12 weeks
Control Intervention1: Placebo: Placebo Capsule oral twice daily morning evening for 12 weeks


Primary outcome:

1. SARS-CoV 2 infection rate Using RTPCRTimepoint: 12 weeks

Criteria:

Inclusion criteria: People at risk of SARS-CoV 2 infection ( healthcare professionals , attendants of COVID patients , non COVID patients admitted in hospitals or his risk groups like elderly , cardiovascular patients , diabetes , obesity )

Not having a previous COVID19 diagnosis

Not having experienced COVID19 symptoms since 30 th Jan 2020.

Not having taken any pre-exposure prophylaxis ( HCQ , any other medication or Ayurvedic preparation or food supplement )

Having a negative SARS-CoV 2 test before randomisation

Exclusion criteria: Any chronic infection

Renal failure (CrCl < 60 mL/min/1.73 m2) or need for hemodialysis

Known history of hypersensitivity to the study drug or any of its components

Immune suppressant drugs

Recent vaccination within 2 month

Pregnancy

Primary Immunodeficiency states • Anemia

Leukopenia

Thrombocytopenia

Co morbidities precluding survival required for duration of study follow up

5.
CTRI; 04-06-2020; TrialID: CTRI/2020/06/025613
Clinical Trial Register | ICTRP | ID: ictrp-CTRI202006025613

ABSTRACT

Intervention:

Intervention1: Melatonin: Oral melatonin 3 mg at 6 pm daily once x 8 weeks
Control Intervention1: Placebo: Placebo for 8 weeks


Primary outcome:

SARS-CoV 2 infection rate : Number of confirmed (positive CRP) symptomatic infections in each treatment group

Timepoint: 8 weeks

Criteria:

Inclusion criteria: High groups for COVID 19 related disease

Elderly : age > 60 years

Diabetes

Obesity

Heart Failure

Immuno supressed patients



Exclusion criteria: Chronic Renal Failure

Chronic Hepatic Failure

Any hospitalisation for past 3 months

Any recent vaccination

Nutrition supplements

Any addiction

Chronic infections live Human immunodeficiency disorder , Hepatitis B,C., etc

Any autoimmune disease

Irregular sleep pattern

Primary immunodeficiency states

Vitamin deficiency states

6.
CTRI; 16-05-2020; TrialID: CTRI/2020/05/025216
Clinical Trial Register | ICTRP | ID: ictrp-CTRI202005025216

ABSTRACT

Intervention:

Intervention1: Nil: Nil
Control Intervention1: Nil: Nil


Primary outcome:

No of patients with QT prolongation by 25 percentage of baseline

No of patients with QT prolongation greater than 500 ms

No of patients with ventricular arrhythmias

Syncope

Sudden cardiac DeathTimepoint: 7 days

Criteria:

Inclusion criteria: people taking pre exposure COVID 19 hydroxychloroquin prophylaxis

Written informed consent

Exclusion criteria: Corrected QT greater than 480 ms

Known congenital Long QT

Co moralities and contraindications to hydroxychloroquin

Retinopathy

Known hypersensitivity to chloroquine

Cardiomyopathy, prolonged QTc, cardiac arrhythmias • History of psoriasis, porphyria cutanea tarda

Epilepsy

Myasthenia gravis, myopathy of any cause

Serious hepatic or renal disease

Known glucose-6-phosphate dehydrogenase deficiency

Current use of medication with known serious hepatotoxic effects or known interaction with chloroquine

Severe depression

Electrolyte imbalance

Anti arrhythmic drugs

Cardiac devices like pacemaker , defibrillators

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