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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID -19

Intervention / Treatment
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* Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins
* Drug: Oral low dose steroid
* Drug: Intravenous Antibiotics with Low dose steroid.
* Drug: Oral anti-coagulant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID -19 positive patients under home quarantine Patients consulting online on the 3rd or 4th day after the onset of symptoms. Patients with oxygen saturation 94% and above. Exclusion Criteria: Patients consulting online on or after 5th day of onset of symptoms. Patients with oxygen saturation less than 94% during the initial presentation. Systemic disease known to increase CRP levels.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild<br>Patients with mild symptoms and normal CRP. | Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins<br>* Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D<br>|
| Experimental: Moderate<br>Patients with mild symptoms and less than 10 fold increase in CRP. | Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins<br>* Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D<br>Drug: Oral low dose steroid<br>* Low dose oral methyl prednisolone was added.<br>Drug: Oral anti-coagulant<br>* Rivaroxaban was given for minimum 4 weeks depending on D dimer levels<br>|
| Experimental: Severe<br>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.<br>* Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given<br>Drug: Oral anti-coagulant<br>* Rivaroxaban was given for minimum 4 weeks depending on D dimer levels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of home quarantined COVID -19 positive patients requiring admission in a hospital for hypoxia. | 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. | Two weeks from the onset of symptoms. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of home quarantined COVID -19 patients developing thromboembolic complications | Thromboembolic complications in COVID-19 positive patients under home quarantine were assessed using an online questionnaire. | Four weeks from the time of initial presentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Intervention prior to onset of hypoxia, COVID -19;, Home quarantine;, C-Reactive Protein (CRP);, D-Dimer,