C Reactive Protein in Home Quarantined Coronavirus Disease 2019 (COVID -19) Patients.

Sponsor

Manimarane Arjunan, MD,DM (Cardiology) (Other)

Overall Status

Completed

CT.gov ID

NCT04935515

Collaborator

UR Anoop Research Group (Other)

Enrollment

Location

Arms

1.7

Actual Duration (Months)

14.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

During the peak of the second COVID -19 wave, the hospitals were over-crowded. Many COVID -19 positive patients had to stay at home and reach out to their family physicians for guidance. Medical follow-up for these patients was a daunting challenge. As in - patient hospital facilities were not readily accessible due to over crowding, early objective tests to identify home quarantined patients prone to deterioration and timely medical intervention to avoid hospitalization were required.

Based on early assessment of inflammatory markers like CRP and clinical signs like persistent high-grade fever, need-based early medical intervention was initiated in home quarantined COVID -19 patients prior to the onset of hypoxia, in order to avoid complications and hospitalization

Condition or Disease	Intervention/Treatment	Phase
COVID -19	Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins Drug: Oral low dose steroid Drug: Intravenous Antibiotics with Low dose steroid. Drug: Oral anti-coagulant	N/A

Detailed Description

25 home quarantined COVID -19 patients who contacted online for medical guidance underwent clinical and biochemical evaluation. Radiological evaluation was done only if indicated.

Based on early objective biochemical tests like elevated CRP and clinical signs like persistent high-grade fever on the third or fourth day after onset of symptoms, early medical treatment was initiated prior to onset of hypoxia.

All the 25 patients recovered without any complications and did not require hospitalization.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

C Reactive Protein Based Early Intervention for Home Quarantined COVID -19 Patients to Avoid Complications and Hospitalization.

Actual Study Start Date :

Apr 15, 2021

Actual Primary Completion Date :

May 9, 2021

Actual Study Completion Date :

Jun 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mild Patients with mild symptoms and normal CRP.	Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D
Experimental: Moderate Patients with mild symptoms and less than 10 fold increase in CRP.	Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D Drug: Oral low dose steroid Low dose oral methyl prednisolone was added. Drug: Oral anti-coagulant Rivaroxaban was given for minimum 4 weeks depending on D dimer levels
Experimental: Severe Patients with high grade fever persisting even on the third or fourth day after onset of symptoms or 10 fold or more increase in CRP.	Drug: Intravenous Antibiotics with Low dose steroid. Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given Drug: Oral anti-coagulant Rivaroxaban was given for minimum 4 weeks depending on D dimer levels

Arm

Intervention/Treatment

Experimental: Mild

Patients with mild symptoms and normal CRP.

Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins

Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D

Experimental: Moderate

Patients with mild symptoms and less than 10 fold increase in CRP.

Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins

Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D

Drug: Oral low dose steroid

Low dose oral methyl prednisolone was added.

Drug: Oral anti-coagulant

Rivaroxaban was given for minimum 4 weeks depending on D dimer levels

Experimental: Severe

Patients with high grade fever persisting even on the third or fourth day after onset of symptoms or 10 fold or more increase in CRP.

Drug: Intravenous Antibiotics with Low dose steroid.

Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given

Drug: Oral anti-coagulant

Rivaroxaban was given for minimum 4 weeks depending on D dimer levels

Outcome Measures

Primary Outcome Measures

Number of home quarantined COVID -19 positive patients requiring admission in a hospital for hypoxia. [Two weeks from the onset of symptoms.]
Oxygen saturation in COVID-19 positive patients was monitored using pulse oximetry at home. Those patients who developed hypoxia (less than 94%) were referred for hospitalization.

Secondary Outcome Measures

Number of home quarantined COVID -19 patients developing thromboembolic complications [Four weeks from the time of initial presentation]
Thromboembolic complications in COVID-19 positive patients under home quarantine were assessed using an online questionnaire.