COVID19
Conditions
Keywords
covid 19, treatment
Brief summary
To find the effectiveness of hydroxychloroquine alone and adjuvant with azithromycin in mild to severe Covide-19 pneumonia patients admitted to Coronavirus cell/ward of Ayub Teaching hospital, Abbottabad Pakistan. A single centered, single-blind randomized control trial study.
Detailed description
Coronavirus (SARS-nCoV-2) is a member family coronaviridae, order Nidovirales. It is single-stranded, positive sense enveloped RNA discovered in early 1960s. Coronavirus pandemic put a lot of lives at stake. By 19 March 2020, a total of 219238 confirmed cases with 8967 being dead and 85742 recovered cases have been reported. Worldwide, in 9 days, the confirmed death cases have been doubled. The average death rate of Covid-19 per day is approximately 88 patients as of the given date. Unlike, SARS-CoV and MERS-CoV, the disease progression and mortality rate of Covid-19 is startling. The pre-pathogenic course of novel Covid-19 is yet to be determined, so the risk factors, clinical picture and medical intervention too. Only supportive therapy is being practised. Yet many trials of antimalarial drug, chloroquine and quinolone is currently taking place worldwide. According to Cortegiani A, 23 ongoing trials from China have been registered. Clinical experience from recent Wuhan epidemic came up with promising results of chloroquine and hydroxychloroquine in Covid-19 positive patients. Some in-vitro studies suggest that these immunomodulant drugs can interfere with SARS-nCov-2 replication. These are federal drug authority approved medicine for malaria. Yet their effectiveness and safety in treating Covid-19 pneumonia is a question mark.
Interventions
Hydroxychloroquine administered orally with water
DRUGAzithromycin 500Mg Oral Tablet
Azithromycin administered orally with water
DIETARY_SUPPLEMENTGlucose tablets
administered orally with water
Sponsors
Ayub Medical College, Abbottabad
Prof. Dr. Umar Farooq
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single blinded: As, the disease is novel and putting the lives at risk is unethical. therefore, It is important for investigator to know the group and carry close regular monitoring of participants so that proper further intervention can be made when required.
Intervention model description
three parallel groups randomly asserted for intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed cases of Covid-19 (all by RT-PCR from same laboratory) * Mild to severe clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)
Exclusion criteria
* Covid-19 critically ill patients (NEWS-2 score \<7), * Unable to take oral medication, * Immunocompromised, * Creatinine clearance (CCL) \< 30 ml/min, * Aspartate transaminase (AST) or alanine transaminase (ALT) \> 5 times Upper limit of normal (ULN), * d-dimer \> 2microgram per liter, or * Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy, * BMI less than 18 * Smoking history (one pack per day) for past six months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Early Warning Score equal to zero | 3-5 Days | National Early Warning Score equal to zero is when patients recovered clinically. Respiration 14-20breaths/minute, oxygen saturation percent greater than 96, (without breathing aid), systolic blood pressure 111-180 mmhg, pulse 60-90 beats.minute, alert consciousness and 35.1-38 degree Celsius body temperature. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive proteins | 3-5 Days | below 3.0 miligram/Liter of blood sample |
| Lymphocyte Count | 3-5days | 1000 -4800 lymphocytes in 1 microliter of blood |
| d-dimers | 3-5days | less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample |
Countries
Pakistan
Contacts
Primary ContactUmar Farooq, PhD
Backup ContactMuhammad J Khan, MBBS
Outcome results
None listed