Saliva PCR in Pregnant Women with COVID-19

NCT06735300 | Completed

• 1 other identifier: IRB: B-ER-111-164
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract: Objectives We aim to study the relative viral load using saliva polymerase chain reaction among pregnant women treated with Paxlovid. Methods Pregnant women with coronavirus disease 2019 were allocated to two groups: those receiving Paxlovid and those receiving no antiviral agents. We compared the nasopharyngeal and salivary relative viral loads and their changes in saliva specimens. Results Among the 38 pregnant women, seventeen received Paxlovid, and 21 received no antiviral agents. The viral cycle threshold value of saliva was significantly higher than that from nasopharynx, with a median ± interquartile range of 26.44 ± 7.68 versus 17.6 ± 9.6 in the Paxlovid group (p = 0.005). Following treatment, the Paxlovid group showed a significant decrease in relative saliva viral load (cycle threshold value on Day 4/Day 5 minus Day 0) compared to the non-antiviral group (13.40 ± 5.64 versus -1.59 ± 9.63, p = 0.021). The detection rate of coronavirus disease 2019 using salivary polymerase chain reaction was 81.6% (31/38). Conclusions This study showed that saliva is a useful diagnostic tool for coronavirus disease 2019 in pregnant women, and a significant decrease in the relative viral load of saliva was observed in those treated with Paxlovid.

Conditions

Coronavirus Disease 2019 (COVID-19) Pneumonia

Keywords

severe acute respiratory syndrome coronavirus 2; pregnancy; nirmatrelvir/ritonavir 25 (Paxlovid); saliva

Outcome Measures

Primary Outcomes (1)

• Salivary viral load

  The amount of decrease in salivary viral load after taking Paxlovid

  From enrollment to the end of treatment at 7 days

Interventions

Nirmatrelvir/Ritonavir (Paxlovid) DRUG

After providing the potential benefits and associated risks of antiviral treatment with Paxlovid, patients made well-informed decisions about whether or not to receive Paxlovid (300/100 mg nirmatrelvir/ritonavir, Pfizer Inc., New York, NY, USA) twice daily for 5 days.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

From 1 June 2022 to 7 October 2022, 56 pregnant women were screened for eligibility, of which 38 were included in the analysis. Of these, 17 pregnant women were administered Paxlovid, and 21 pregnant women were not administered any antiviral treatment. The two groups of pregnant women were comparable across the two cohorts, except for an earlier gestational age at diagnosis of COVID-19 in the Paxlovid group than in the non-antiviral group (35.4 weeks versus 37.5 weeks, p = 0.022). Among women treated with Paxlovid, 47.1% had gestational complications compared with 9.5% of those without antiviral treatment (p = 0.012).

You may qualify if:

• This study enrolled pregnant women admitted to NCKUH 70 who tested positive for COVID-19 by real-time reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swab specimens. After providing the potential benefits and associated risks of antiviral treatment with Paxlovid, patients made a well-informed decision about whether or not to receive Paxlovid (300/100 mg nirmatrelvir/ritonavir, Pfizer Inc., USA) twice daily for 5 days.

You may not qualify if:

• Pregnant women were excluded if the time interval between the onset of symptoms and admission to our hospital was greater than seven days, in the case of insufficient saliva samples, or if any antiviral-related agents were administered, such as remdesivir, glucocorticoids, or interleukin-6 receptor antagonists.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng 68 Kung University Hospital

Tainan, 704, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal specimens and saliva for RT-PCR.

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

nirmatrelvir; Ritonavir; nirmatrelvir and ritonavir drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: June 1, 2022
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)