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

Not Applicable

Completed

• Conditions: COVID -19
• Interventions: Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins; Drug: Intravenous Antibiotics with Low dose steroid.; Drug: Oral low dose steroid; Drug: Oral anti-coagulant

• Registration Number: NCT04935515
• Lead Sponsor: Manimarane Arjunan, MD,DM (Cardiology)

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

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 Timeline

• Study Start: 2021-04-15
• Primary Completion: 2021-05-09
• Status Verified: 2021-06
• Study Completion: 2021-06-06
• Study First Submitted: 2021-06-20
• Study First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. COVID -19 positive patients under home quarantine
2. Patients consulting online on the 3rd or 4th day after the onset of symptoms.
3. Patients with oxygen saturation 94% and above.

Exclusion Criteria

1. Patients consulting online on or after 5th day of onset of symptoms.
2. Patients with oxygen saturation less than 94% during the initial presentation.
3. Systemic disease known to increase CRP levels.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild	Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins	Patients with mild symptoms and normal CRP.
Moderate	Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins	Patients with mild symptoms and less than 10 fold increase in CRP.
Moderate	Oral low dose steroid	Patients with mild symptoms and less than 10 fold increase in CRP.
Moderate	Oral anti-coagulant	Patients with mild symptoms and less than 10 fold increase in CRP.
Severe	Intravenous Antibiotics with Low dose steroid.	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.
Severe	Oral anti-coagulant	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

ONLINE; 🇮🇳 Puducherry, India