International Journal of Community Medicine and Public Health

Purushothaman S et al. Int J Community Med Public Health. 2023 Feb;10(2):723-728

http://www.ijcmph.com

pISSN 2394-6032 | eISSN 2394-6040

Original Research Article

DOI: https://dx.doi.org/10.18203/2394-6040.ijcmph20230228

Multi-center study to analyse outcome of integrated treatment approach in COVID-19 patients

Suraj Purushothaman1, Prashant Kumar Dhotre1*, Kamlesh Prakash Vanarase2, Gajanan Kisan Jadhao2, Abhay Gyanchand Maurya2, Sanjay Mohnalal Gupta2, Vijaykumar Gawali3

1Department of Critical Care, 2Medical Officer, 3Department of Medical Research and Education, Bhaktivedanta Hospital and Research Institute, Mira Road, Maharashtra, India

Received: 23 November 2022

Revised: 14 January 2023

Accepted: 16 January 2023

*Correspondence:

Dr. Prashant Kumar Dhotre,

E-mail: pdhotre@gmail.com, drvijay

Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Background: This study presents the outcome of integrated treatment approach based on government mandated standard allopathic treatment along with alternatives in COVID-19 patients. The aim of our study was to investigate the outcome of treatment strategy, co-morbid status, recovery and mortality rate of COVID-19 patients at Bhaktivedanta Hospital and Research Institute.

Methods: Post ethics committee approval for multiple centers, data for 1049 COVID-19 patients (RTPCR confirmed cases) of all age groups and genders which were admitted in a dedicated covid hospital from March 2020 to November 2020 was analysed retrospectively.

Results: This study highlights the management of COVID-19 patients with an integrated approach. In our cohort with 36.7%, 44.70 %, 18.58% of mild, moderate and severe cases respectively, mortality rate was only 3.43% of total positive patients admitted at our hospital.

Conclusions: We emphasize that even in healthcare facilities with limited resource and poor infrastructure and lack of ICU facilities, clinical observation-based management can help to reduce mortality considerably. Unique features of our study include use of progesterone as an immune modulator, use of dual antiviral agents and use of age-related lower limit of oxygen saturation.

Keywords: COVID-19, Limited resource setting, Minimal use of oxygen, Mortality, Patient outcome, Progesterone as immunomodulator, Treatment strategy

INTRODUCTION

COVID-19 pandemic is a public health emergency which poses lot of pressure on health care systems. Most of the patients with COVID-19 infection has mild symptoms (80%) and moderate symptoms (14%) and significant proportion of patients with co-morbidities and other complications require timely hospitalization to reduce risk of mortality.1 Integrated approach can help manage the symptoms/treatment in the vulnerable population with complex symptoms.2

There are various current treatments which exists and include anti-inflammatory drugs like statins, antiviral drugs like remdesivir, anticoagulants and antibody therapy which produce different levels of therapeutic effects on patients.2 It has also been noticed that patients with COVID-19 and having some underlying cardiovascular diseases have shown and increased rate of mortality upto 10.5%.3 The drugs commonly used in covid era like remdesivir and tocilizumab were commonly used allopathic drugs but these drugs posed some problems. Hence, it is worthwhile to have an alternate approach as well. Here we are presenting the outcome of integrated treatment approach based on government mandated standard allopathic treatment along with alternatives in COVID-19 patients. The aim of our study was to investigate outcome of treatment strategy, co-morbid status, recovery and mortality rate of COVID-19 patients at Bhaktivedanta Hospital and Research Institute.

METHODS

The study was initiated after obtaining approval from the Institutional Ethics Committee and approval from the Ministry of Health (EC/NEW/INST/2019/245). In this multicentre retrospective study, data of 1049 consecutive discharged and death patients with COVID-19 positive by rRT-PCR (nucleic acid amplification) test was included and analysed. The patients were admitted in a dedicated COVID-19 hospital including all genders and age groups from March 2020 to November 2020 were included in the study. Patients who did not have COVID-19 test done were excluded from the study. All patients received appropriate supportive care and regular clinical and laboratory monitoring. Patients information inclusive of demographics (age, sex, nationality), clinical features including severity based on saturation on air at the time of admission and CT severity score; co-morbid conditions, number of patients requiring BiPAP, date of admission and discharge, patient mortality rate, nCoronavirus, rRT-PCR and other laboratory results were extracted from medical records.

Apart from the exercise schedule, emphasis was also put on therapeutic positioning. Patients were clinically observed to explore most appropriate position in order to ensure optimal saturation. Various position viz sitting, standing, left lateral, right lateral, semi-prone, prone, head low, supine were assessed. Best and worst positions was documented. Best position was used whenever patient showed worsening of saturation. Age specific lower limit of acceptable oxygen saturation was followed as per respiratory care guide for clinical practice. Following are the treatments given to patients who maintained SpO2 levels above 94 and were categorized as mild cases (Table 1a). First, a 1600 mg dose of favipiravir tablet was given twice daily on day 1, then 800 mg twice daily for the following seven days while uric acid levels were continuously monitored. For seven days, a 200 mg Doxy tablet was administered stat and then twice daily. Ivermectin tablets were given out in a single dose of 12 mg. An intramuscular injection of vitamin D was given at a dose of 1/3 6 lac units. Additionally, 75 mg of aspirin was administered each day. For patients categorized as moderate to severe (Table 1b); remdesivir was administered intravenously on day 1 in doses of 200 mg and 100 mg for the following five days. Only when absolutely necessary was a 40 mg dose of methyl prednisolone intravenous injection given. According to the need for mechanical ventilation and the demand for oxygen, the steroid dose was altered. Depending on the coagulation parameters, a second subcutaneous injection of alexam/clexane at a dose of 0.6 mg was given. An intramuscular injection of vitamin D was given at a dose of 1/3 6 lac units. Aditionally, 75 mg of aspirin was administered each day. Descriptive statistics were reported as mean (SD) or median for continuous variables and as counts and percentages for categorical variables. No imputation was made for missing data. Analyses were performed with the use of SPSS version 20.

Table 1a: Treatment given to patients who maintained SpO2 levels above 94 and were categorized as mild cases.
Table reproduced from source PDF page 2
Table 1b: Treatment given to patients categorized as moderate to severe.
Table reproduced from source PDF page 2

RESULTS

Data of total of 1049 patients of laboratory confirmed COVID-19 test by RT-PCR at Bhakti Vedanta Hospital and Research Institute was analysed. The mean age of patients was 49.19 (SD 14.1) years and 752 (74.07%) of them were males. A summary of demographic characteristics of the study participants is represented in Table 2. The three most prominent management strategies in combination with ayurvedic treatment included the use of steroids (42.70%; n=448), remedisivir (36.3%; n=384), and tocilizumab (6.76%; n=71). Clinical severity of patients was assessed on the basis of CT severity and SPO2 recorded at the time of admission. Patients were categorized as mild, moderate, severe as per CT severity and SPO2 recorded at the time of admission, clinical guidance for management of adult COVID-19.2 385 (36.7%) were mild cases, 469 (44.70%) cases were moderate remaining 195 (18.58%) were severe cases (Figure 1). Of all patients 36 (3.43%) patients expired and remaining 1013 patients have subsequently recovered and were discharged. Median duration of stay in the hospital was 9 (37) days. Patients had one or more co-morbidities.

Table 2: Demographic characteristics of the study participants (N=1049).
Table reproduced from source PDF page 3
Figure 1: Clinical severity of patients on the basis of CT severity score and SpO2 level at the time of admission | Mild cases as per CT severity score and SPO2 level at admission , 385 Moderate cases as per CT severity score and SPO2 level at admission , 469 Severe cases as per CT severity score and SPO2 level at admission , 195
Figure 1: Clinical severity of patients on the basis of CT severity score and SpO2 level at the time of admission

Diabetes mellitus was the leading co-morbid condition with frequency of 30.2% followed by ischemic heart disease (6.6%), CKD (2.95%), asthma (2.19%), COPD (0.47%), ILD (0.28%) and bronchitis (0.1%) (Figure 2). Overall mortality of patients was 3.43%. Patients with different co-morbid conditions requiring Bipap support and their outcome is shown in Table 2.

Figure 2: Co-morbid conditions (number of patients). | 317 70 31 27 6 0 50 100 150 200 250 300 350 Diabetes Ischemic heart disease Chronic kidney disease Asthma COPD Noofpatients Co - morbid conditions
Figure 2: Co-morbid conditions (number of patients).

DISCUSSION

We report outcome of the 1049 patients admitted to Bhaktivedanta hospital and research institute. Mean age of the patient was found to be 49.19 years. As per studies reported earlier risk of severe COVID-19 illness and mortality is higher among men, elderly, and in individuals with comorbidities, especially diabetes.3 Our data shows that more males (71.68%) are infected as compared to females which is consistent with the result of other studies reported earlier with ranges between 60-93%.4-9

The presence of comorbidities such as diabetes mellitus (DM), hypertension (HTN), chronic obstructive pulmonary disease (COPD) or old age leads to poorer clinical outcomes in COVID-19 patients.10-14 Our finding are similar to these studies Table 3.

Table 3: Outcome of patients.
Table reproduced from source PDF page 4
Table 4: Summary of outcomes mortality of various COVID-19 studies reported.
Table reproduced from source PDF page 4

However as compared to some other studies death in co morbid conditions is less in our study which reflects an improved outcome with the integrated approach adopted by our hospital.28-30 In our study, the most common comorbidities were diabetes followed by cardiovascular problems. Similar results were reported by Liu et al in a systematic review and metanalysis comprising of 24 peer reviewed articles.31

Better clinical outcomes were observed as apart from required treatment, regular monitoring of CBC, D-dimer levels, creatinine and liver enzymes (SGOT/ SGPT) were conducted. Additionally, Ayurcov as adjuvant with standard of care was associated with significantly earlier resolution of COVID-19 related symptoms than standard of care alone.32 Also all patients were clinically monitored for heart rate, SpO2, respiratory rate. Patients also were monitored twice a day by the min walk test to assess for progressing hypoxia. All patients after 7-10 days of illness and on 5 litres O2 or less were trained by a cardiorespiratory physiotherapist in breathing exercises which were mandatory to be performed 4 times per day. The exercises incorporated were diaphragmatic breathing, thoracic expansion exercises and segmental expansion exercises. Breath holding and use of incentive spirometer were avoided. Along with the breathing exercises, all patients were asked to undertake walking as a form of aerobic activity starting with as less as 2-5 minutes/session. The entire exercise schedule including breathing and walking were repeated at least 3-5 times/day. This study highlights the management of COVID-19 patients with an integrated approach. In our cohort with 36.7%, 44.70%, 18.58% of mild, moderate and severe cases respectively, mortality rate was only 3.43% of total positive patients admitted at our hospital. In a study reported by Macedo et al the mortality rate was reported to be 17.1%.31 We also found that mortality was low in Indian subcontinent as compared western countries (Table 4).

The limitation of the study is that, firstly, it was only conducted at one centre. Secondly, since the study was retrospective in nature, the analysis was based on existing patient data.

CONCLUSION

We emphasize that even in healthcare facilities with limited resource and poor infrastructure and lack of ICU facilities, clinical observation-based management can help to reduce mortality considerably. Unique features of our study include the use of progesterone as an immunomodulator, use of dual antiviral agents and use of age-related lower limit of oxygen saturation.

ACKNOWLEDGEMENTS

Authors would like to thank Ms. Vrutti Hitendrakumar Mistry for data collection process and processing paper publication.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Ministry of Health (EC/NEW/INST/2019/245)

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