COVID -19NCT04935515
C Reactive Protein in Home Quarantined Coronavirus Disease 2019 (COVID -19) Patients.
A study testing Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins, Oral low dose steroid and Intravenous Antibiotics with Low dose steroid. in people with COVID -19, run by Manimarane Arjunan, MD,DM (Cardiology) at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID -19
- What is being tested?
- Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins, Oral low dose steroid and Intravenous Antibiotics with Low dose steroid.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- 15 Apr 2021to 6 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: C Reactive Protein Based Early Intervention for Home Quarantined COVID -19 Patients to Avoid Complications and Hospitalization.
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
Read the 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.
- Conditions
- COVID -19
- Being tested
- Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins, Oral low dose steroid, Intravenous Antibiotics with Low dose steroid., Oral anti-coagulant
- Keywords
- COVID -19;, Home quarantine;, C-Reactive Protein (CRP);, D-Dimer,, Early Intervention prior to onset of hypoxia
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Antibiotic, Antihistamine, Anti-inflammatory, MultivitaminsDrug
Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D
Oral low dose steroidDrug
Low dose oral methyl prednisolone was added.
Intravenous Antibiotics with Low dose steroid.Drug
Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given
Oral anti-coagulantDrug
Rivaroxaban was given for minimum 4 weeks depending on D dimer levels
| Study group | Role | What they receive |
|---|---|---|
| Mild | Experimental | Patients with mild symptoms and normal CRP. Receives: Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins |
| Moderate | Experimental | Patients with mild symptoms and less than 10 fold increase in CRP. Receives: Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins; Drug: Oral low dose steroid; Drug: Oral anti-coagulant |
| Severe | Experimental | 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. Receives: Drug: Intravenous Antibiotics with Low dose steroid.; Drug: Oral anti-coagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks from the onset of symptoms.
Secondary outcomes (1)
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.
Measured: Four weeks from the time of initial presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start15 Apr 2021
- Primary completion9 May 2021
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID -19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manimarane Arjunan, MD,DM (Cardiology)
- Sponsor type
- University, hospital or other
- Collaborators
- UR Anoop Research Group
- Responsible party
- Sponsor-investigator, Manimarane Arjunan, MD,DM (Cardiology), UR Anoop Research Group
- Investigators
- MANIMARANE ARJUNAN, MD,DM-CARDIO, Principal investigator, UR Anoop Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935515
- Sponsor's protocol ID
- 1/MA/URA/21
- Status last verified
- Jun 2021
- First submitted
- 20 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C Reactive Protein Based Early Intervention for Home Quarantined COVID -19 Patients to Avoid Complications and Hospitalization.
- ClinicalTrials.gov ID
- NCT04935515
- Acronym / sponsor ID
- 1/MA/URA/21
- Conditions
- COVID -19
- Keywords
- COVID -19;, Home quarantine;, C-Reactive Protein (CRP);, D-Dimer,, Early Intervention prior to onset of hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Manimarane Arjunan, MD,DM (Cardiology)University, hospital or other
- Collaborators
- UR Anoop Research Group
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 9 May 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild | Experimental | Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, MultivitaminsPatients with mild symptoms and normal CRP. |
| Moderate | Experimental | Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins, Drug: Oral low dose steroid, Drug: Oral anti-coagulantPatients with mild symptoms and less than 10 fold increase in CRP. |
| Severe | Experimental | Drug: Intravenous Antibiotics with Low dose steroid., Drug: Oral anti-coagulantPatients with high grade fever persisting even on the third or fourth day after onset of symptoms or 10 fold or more increase in CRP. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Antibiotic, Antihistamine, Anti-inflammatory, MultivitaminsOral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D | Drug | Mild, Moderate |
| Oral low dose steroidLow dose oral methyl prednisolone was added. | Drug | Moderate |
| Intravenous Antibiotics with Low dose steroid.Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given | Drug | Severe |
| Oral anti-coagulantRivaroxaban was given for minimum 4 weeks depending on D dimer levels | Drug | Moderate, Severe |
Primary outcome
Number of home quarantined COVID -19 positive patients requiring admission in a hospital for hypoxia.
Time frame: 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.
1 secondary outcome
Number of home quarantined COVID -19 patients developing thromboembolic complications
Time frame: Four weeks from the time of initial presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MANIMARANE ARJUNAN, MD,DM-CARDIO principal investigator
UR Anoop Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins, Oral low dose steroid and Intravenous Antibiotics with Low dose steroid. in people with COVID -19, run by Manimarane Arjunan, MD,DM (Cardiology) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of home quarantined COVID -19 positive patients requiring admission in a hospital for hypoxia. (time frame: Two weeks from the onset of symptoms.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.