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

COVID -19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04935515
• Other study ID #: 1/MA/URA/21
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: June 6, 2021

Study information

• Verified date: June 2021
• Source: UR Anoop Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 6, 2021
• Est. primary completion date: May 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID -19

Intervention

Drug:
• Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins
Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D
• Oral low dose steroid
Low dose oral methyl prednisolone was added.
• Intravenous Antibiotics with Low dose steroid.
Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given
• Oral anti-coagulant
Rivaroxaban was given for minimum 4 weeks depending on D dimer levels

Locations

Country	Name	City	State
India	ONLINE	Puducherry

Sponsors (2)

Lead Sponsor	Collaborator
Manimarane Arjunan, MD,DM (Cardiology)	UR Anoop Research Group

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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